Stealthserver Image Storage and Communication System
FDA 510(k) K984000 · Surgical Navigation Technologies, Inc.
Submission
- Device name
- Stealthserver Image Storage and Communication System
- Applicant
- Surgical Navigation Technologies, Inc.
Broomfield, CO, US - Received
- November 10, 1998
- Decision date
- January 12, 1999
- 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…
Other 510(k)s with product code LMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K994329 | Iivs Integrated Image Viewing StationLMD · Traditional | Terarecon,Inc. | 05/26/2000SE |
| K992698 | Stentor, PageviewLMD · Traditional | Stentor, Inc. | 10/25/1999SE |
| K992426 | Raypax Web Clinical SystemLMD · Traditional | Samsung Sds Co., Ltd. | 10/13/1999SE |
| 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 |
| 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 |
| K980684 | VR NetserveLMD · Traditional | I.S.G. Technologies, Inc. | 05/06/1998SE |
More from I.S.G. Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000246 | Radiocameras Extracranial SystemIYE · Traditional | 10/20/2000SE |
| K994355 | Radiocameras System Head/Neck ApplicationIYE · Traditional | 03/22/2000SE |
| K992461 | Stealthstation Treatment Guidance PlatformHAW · Traditional | 02/22/2000SE |
| K992927 | Stealthstation Treatment Guidance PlatformHAW · Traditional | 12/29/1999SE |
| K993021 | Metrx SystemHRX · Traditional | 11/10/1999SE |
| K992354 | SNT Image Analysis SystemLLZ · Traditional | 10/12/1999SE |
| K991468 | Immerge Image CorrelationLLZ · Traditional | 07/06/1999SE |
| K990214 | Fluoronav Module for the Stealthstation SystemHAW · Traditional | 04/22/1999SE |
| K983670 | Stealthstation SystemHAW · Traditional | 01/14/1999SE |
| K983397 | Stealthstation Treatment Guidance PlafformHAW · Traditional | 12/04/1998SE |
Questions and answers
When was Stealthserver Image Storage and Communication System cleared by the FDA?
Stealthserver Image Storage and Communication System (K984000) received a 510(k) decision of Substantially Equivalent on January 12, 1999, 63 days after the submission was received.
What is the product code of K984000?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.