Device, Digital Image Storage, Radiological
FDA product code LMB · Class I (low risk) · 21 CFR 892.2010 · Radiology
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
55510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Eastman Kodak Company 4
- Eigen 3
- Camtronics, Ltd. 3
- Base Ten Systems, Inc. 2
- Sectra-Imtec AB 2
- Olympus Corp. 2
- Andros Analyzers, Inc. 2
- O Tech, Inc. 2
- Sony Medical Systems 2
- Philips Medical Systems North America, Inc. 1
- Novus Technologies, Inc. 1
- Perkins Mfg. Co. 1
- Vortech Data, Inc. 1
- Ausonics Pty , Ltd. 1
- Adac Laboratories 1
- Contour Medical Systems, Inc. 1
- Samsung Sds Co., Ltd. 1
- General Electric Co. 1
- Advanced Nuclear Imaging Corp. 1
- Sigma Teleproducts, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992131 | Samsung Raypax Long Term ArchiveLMB · Traditional | Samsung Sds Co., Ltd. | 09/13/1999SE |
| K984405 | Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000LMB · Traditional | Intracom Corp. | 02/08/1999SE |
| K983447 | Wise (II) Image Management SystemLMB · Special | Sectra-Imtec AB | 10/29/1998SE |
| K980243 | Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)LMB · Traditional | Parameter Developments, Inc. | 04/03/1998SE |
| K973463 | Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveLMB · Traditional | O Tech, Inc. | 12/02/1997SE |
| K973413 | Id. Store (Release 2.0)LMB · Traditional | I.S.G. Technologies, Inc. | 11/25/1997SE |
| K972380 | Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional | Eastman Kodak Company | 09/11/1997SE |
| K971848 | TDK Medical Grade Cd-RLMB · Traditional | Tdk Electronics Corporation of America | 08/15/1997SE |
| K971451 | Wise Image Management SystemLMB · Traditional | O Tech, Inc. | 06/26/1997SE |
| K963936 | Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional | Biosound, Inc. | 03/31/1997SE |
| K964803 | Univision Echocardiology SystemLMB · Traditional | Network Concepts, Inc. | 02/11/1997SE |
| K964274 | Writestar, and ViewstarLMB · Traditional | Comview Corp. | 01/10/1997SE |
| K963395 | Imageserver 2000 Picture Archiving SystemLMB · Traditional | Sectra-Imtec AB | 10/25/1996SE |
| K961680 | Sony DKR-700 Digital Still RecorderLMB · Traditional | Sony Medical Systems | 07/03/1996SE |
| K961160 | Upacs Version 1.7LMB · Traditional | Base Ten Systems, Inc. | 06/11/1996SE |
| K960981 | Kodak Digital Science(Kds) Medical Image and Information LibraryLMB · Traditional | Kodak Health Imaging Systems, Inc. | 06/07/1996SE |
| K960941 | UpacsLMB · Traditional | Base Ten Systems, Inc. | 06/03/1996SE |
| K951942 | Last Image HoldLMB · Traditional | Insight Systems | 04/08/1996SE |
| K955237 | Tigerscan/TigerviewLMB · Traditional | Tau Corp. | 04/04/1996SE |
| K960326 | FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality SystemLMB · Traditional | Fujifilm Medical System U.S.A., Inc. | 03/07/1996SE |
| K952238 | Vidcas (Video Capture and Archiving Software)LMB · Traditional | Imaging Concepts, Inc. | 02/21/1996SE |
| K955184 | AcculupeLMB · Traditional | E For M Imaging Systems Div., Marquette Electronic | 01/24/1996SE |
| K955232 | NT Series Digital Image ManagerLMB · Traditional | Camtronics, Ltd. | 12/11/1995SE |
| K950630 | Wallach Digital Imaging SystemLMB · Traditional | Wallach Surgical Devices, Inc. | 11/22/1995SE |
| K952888 | Olympus Imagemanager System Version 6.0 for WindowsLMB · Traditional | Olympus America, Inc. | 09/18/1995SE |
| K950279 | TOMTECP90LMB · Traditional | Tomtec Imaging Systems, Inc. | 09/15/1995SE |
| K951141 | Star Technolgies, Inc. Image Management ServerLMB · Traditional | Star Technologies, Inc. | 05/30/1995SE |
| K942558 | InstacineLMB · Traditional | Fidelity Medical, Inc. | 05/30/1995SE |
| K945654 | Nicom Digital Image ManagerLMB · Traditional | Camtronics, Ltd. | 02/17/1995SE |
| K933115 | Digital Disk RecorderLMB · Traditional | Eigen | 04/07/1994SE |
| K935498 | 7500 Data TowerLMB · Traditional | E-Systems, Inc. | 04/01/1994SE |
| K931410 | Novus Image Archive System, Teleradiology SystemLMB · Traditional | Novus Technologies, Inc. | 02/18/1994SE |
| K934889 | Olympus Imagemanager SystemLMB · Traditional | Olympus | 01/28/1994SE |
| K934888 | Olympus ImagemanagersystemLMB · Traditional | Olympus | 01/25/1994SE |
| K926348 | SC1000 Scan ConverterLMB · Traditional | Perkins Mfg. Co. | 11/19/1993SE |
| K923680 | Eltrax Optical Disk Image Archiving SystemLMB · Traditional | Minnetonka Medical | 10/20/1992SE |
| K921275 | Sony Laser Videodisc Recording SystemLMB · Traditional | Sony Medical Systems | 06/10/1992SE |
| K914728 | Kodak Ektascan Imagelink Ultrasound SystemLMB · Traditional | Eastman Kodak Company | 03/02/1992SE |
| K915094 | Vortech's Image Archival and Retrieval SystemLMB · Traditional | Vortech Data, Inc. | 12/27/1991SE |
| K905488 | Doppler Upgrade for Ausonics Opus 1 Real Time ScanLMB · Traditional | Ausonics Pty , Ltd. | 12/18/1991SE |
| K903806 | Angiotec Image Management SystemLMB · Traditional | Andros Analyzers, Inc. | 11/23/1990SE |
| K901956 | Digital 8 W/Other Numerical Suffixes (1-9, Etc.)LMB · Traditional | Eigen | 07/02/1990SE |
| K901118 | Omniview Digital Radiology Imaging SystemLMB · Traditional | Adac Laboratories | 04/10/1990SE |
| K891690 | Kodak Ektascan Image ManagerLMB · Traditional | Eastman Kodak Company | 06/15/1989SE |
| K885327 | Philips Digital Cardiac Imaging (Dci) SystemLMB · Traditional | Philips Medical Systems North America, Inc. | 05/11/1989SE |
| K891485 | Angiotec FMX-2220 SystemLMB · Traditional | Andros Analyzers, Inc. | 05/05/1989SE |
| K884990 | IMS-3 Picture Archiving SystemLMB · Traditional | The Biomedical Engineering Center | 03/23/1989SE |
| K884148 | Diskcam DC 6001LMB · Traditional | Camtronics, Ltd. | 11/23/1988SE |
| K882184 | HR-1000 W/Suffixes (B,C or D)LMB · Traditional | Eigen | 06/28/1988SE |
| K873048 | Kodak SV6500 Printer/ SV65 Finisher/ SV100 SetLMB · Traditional | Eastman Kodak Company | 10/30/1987SE |
| K863286 | Ers SystemLMB · Traditional | General Electric Co. | 10/27/1986SE |
| K862842 | Advanced Nuclear ComputerLMB · Traditional | Advanced Nuclear Imaging Corp. | 10/27/1986SE |
| K844132 | Medivision Series 5000 Fluoroscopic Digital ImagerLMB · Traditional | Sigma Teleproducts, Inc. | 01/22/1985SE |
| K843349 | ND3100 Video ImagerLMB · Traditional | Nuclear Data, Inc. | 12/17/1984SE |
| K833525 | CEMAX-1000LMB · Traditional | Contour Medical Systems, Inc. | 11/21/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1762-2017 Class II | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge…An error message can occur resulting in the prior studies being unavailable for viewing. | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-1700-2017 Class II | iConnect Enterprise Archive software.The versions allow images to be stored without pixel data, resulting in the system not being able to present… | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-1697-2017 Class II | iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for…The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in… | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-1470-2017 Class II | iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge…The software produced a number of "do not route" exceptions, which may result in potential patient injury or… | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-2686-2016 Class II | iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland…Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are… | Merge Healthcare, Inc. | 01/30/2016Terminated |
| Z-0833-2015 Class II | Centricity Enterprise Archive is a software product for receiving, archiving and sending…GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting… | Ge Healthcare It | 04/19/2013Terminated |
| Z-2739-2016 Class II | Centricity Enterprise Archive is a software product for receiving, archiving and sending…There is a potential for data loss associated with empty path names resulting from HL-7 updates when the… | Ge Healthcare It | 11/16/2012Terminated |
| Z-2983-2011 | LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi…A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or… | Siemens Medical Solutions USA, Inc | 06/30/2011Terminated |
| Z-2151-2011 | LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1…There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital… | Siemens Medical Solutions USA, Inc | 03/23/2011Terminated |
| Z-1590-2010 | An Imaging device for medical procedures, to provide surgeons or operating room…Video device is not able to assign the correct time/date stamp. | Stryker Endoscopy | 10/23/2009Terminated |
| Z-0134-2010 | Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers…Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on… | Stryker Imaging | 08/31/2009Terminated |
| Z-2316-2009 | Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare…Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where… | GE Healthcare Integrated IT Solutions | 08/14/2009Terminated |
| Z-0160-2010 | Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with…Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis. | Stryker Imaging | 08/03/2009Terminated |
| Z-0168-2010 | Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or…Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on… | Stryker Imaging | 07/31/2009Terminated |
| Z-1316-2008 | Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker…Patient Identification numbers and names may be applied to images from another patient due to a software… | Stryker Endoscopy | 02/15/2008Terminated |