Raypax Web Clinical System
FDA 510(k) K992426 · Samsung Sds Co., Ltd.
510(k) numberK992426
Submission
- Device name
- Raypax Web Clinical System
- Applicant
- Samsung Sds Co., Ltd.
Aubrey, TX, US - Received
- July 21, 1999
- Decision date
- October 13, 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…
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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 |
| K980684 | VR NetserveLMD · Traditional | I.S.G. Technologies, Inc. | 05/06/1998SE |
More from I.S.G. Technologies, Inc.
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|---|---|---|
| K002062 | Samsung 10DR Implant SystemEHD · Traditional | 11/09/2000SE |
| K992306 | Samsung Raypax Display WorkstationLLZ · Traditional | 09/22/1999SE |
| K992131 | Samsung Raypax Long Term ArchiveLMB · Traditional | 09/13/1999SE |
| K992112 | Samsung Raypax Film DigitizerLLZ · Traditional | 09/09/1999SE |
| K991537 | Samsung Raypax SystemLMD · Traditional | 07/06/1999SE |
Questions and answers
When was Raypax Web Clinical System cleared by the FDA?
Raypax Web Clinical System (K992426) received a 510(k) decision of Substantially Equivalent on October 13, 1999, 84 days after the submission was received.
What is the product code of K992426?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.