Preview Teleimaging System
FDA 510(k) K950699 · Regulatory Management Services
510(k) numberK950699
Submission
- Device name
- Preview Teleimaging System
- Applicant
- Regulatory Management Services
San Leandro, CA, US - Received
- February 15, 1995
- Decision date
- May 3, 1995
- 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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| 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 |
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Questions and answers
When was Preview Teleimaging System cleared by the FDA?
Preview Teleimaging System (K950699) received a 510(k) decision of Substantially Equivalent on May 3, 1995, 77 days after the submission was received.
What is the product code of K950699?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.