Samsung Raypax System
FDA 510(k) K991537 · Samsung Sds Co., Ltd.
510(k) numberK991537
Submission
- Device name
- Samsung Raypax System
- Applicant
- Samsung Sds Co., Ltd.
Aubrey, TX, US - Received
- May 3, 1999
- Decision date
- July 6, 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K002062 | Samsung 10DR Implant SystemEHD · Traditional | 11/09/2000SE |
| K992426 | Raypax Web Clinical SystemLMD · Traditional | 10/13/1999SE |
| 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 |
Questions and answers
When was Samsung Raypax System cleared by the FDA?
Samsung Raypax System (K991537) received a 510(k) decision of Substantially Equivalent on July 6, 1999, 64 days after the submission was received.
What is the product code of K991537?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.