Jpacs
FDA 510(k) K980918 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK980918
Submission
- Device name
- Jpacs
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Cleveland, OH, US - Received
- March 11, 1998
- Decision date
- June 3, 1998
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K974882 | Downscan LTLMD · Traditional | Merlin Engineering Works, Inc. | 05/22/1998SE |
| K980684 | VR NetserveLMD · Traditional | I.S.G. Technologies, Inc. | 05/06/1998SE |
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Questions and answers
When was Jpacs cleared by the FDA?
Jpacs (K980918) received a 510(k) decision of Substantially Equivalent on June 3, 1998, 84 days after the submission was received.
What is the product code of K980918?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.