Lumisys Dicom Tooklit
FDA 510(k) K953371 · Lumisys, Inc.
510(k) numberK953371
Submission
- Device name
- Lumisys Dicom Tooklit
- Applicant
- Lumisys, Inc.
San Leandro, CA, US - Received
- July 18, 1995
- Decision date
- October 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LMD – System, Digital Image Communications, Radiological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.2020
- Specialty
- Radiology
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric…
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| K992352 | ITR2000: Internet Teleradiology, Model Release 1.0LMD · Traditional | Inteleradiology, Inc. | 09/29/1999SE |
| K991537 | Samsung Raypax SystemLMD · Traditional | Samsung Sds Co., Ltd. | 07/06/1999SE |
| K984000 | Stealthserver Image Storage and Communication SystemLMD · Traditional | Surgical Navigation Technologies, Inc. | 01/12/1999SE |
| K974707 | ImagequestLMD · Traditional | Visual Med, Inc. | 07/31/1998SE |
| K981053 | Kodak Digital Sciences (KDS) Image ViewLMD · Traditional | Eastman Kodak Company | 06/18/1998SE |
| K980918 | JpacsLMD · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/03/1998SE |
| K974882 | Downscan LTLMD · Traditional | Merlin Engineering Works, Inc. | 05/22/1998SE |
More from Merlin Engineering Works, Inc.
| 510(k) | Device | Decision |
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| K980809 | Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 EraserLMA · Traditional | 05/11/1998SE |
| K980213 | DI-2000LMA · Traditional | 03/17/1998SE |
| K953964 | Lumisys, Lumiscan 20LMA · Traditional | 09/18/1995SE |
| K933129 | Lumiscan 50LMA · Traditional | 10/07/1993SE |
| K902347 | Compact Laser Imager, Model CLI-100LMC · Traditional | 03/04/1991SE |
| K901423 | Digital Image Scanner, Model DIS-1000LMA · Traditional | 04/30/1990SE |
Questions and answers
When was Lumisys Dicom Tooklit cleared by the FDA?
Lumisys Dicom Tooklit (K953371) received a 510(k) decision of Substantially Equivalent on October 18, 1995, 92 days after the submission was received.
What is the product code of K953371?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.