Imagequest
FDA 510(k) K974707 · Visual Med, Inc.
510(k) numberK974707
Submission
- Device name
- Imagequest
- Applicant
- Visual Med, Inc.
Ft. Mill, SC, US - Received
- December 16, 1997
- Decision date
- July 31, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Imagequest cleared by the FDA?
Imagequest (K974707) received a 510(k) decision of Substantially Equivalent on July 31, 1998, 227 days after the submission was received.
What is the product code of K974707?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.