Kodak Digital Sciences (KDS) Image View
FDA 510(k) K981053 · Eastman Kodak Company
510(k) numberK981053
Submission
- Device name
- Kodak Digital Sciences (KDS) Image View
- Applicant
- Eastman Kodak Company
Dallas, TX, US - Received
- March 23, 1998
- Decision date
- June 18, 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…
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| K980918 | JpacsLMD · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/03/1998SE |
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| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | 09/24/2004SE |
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Questions and answers
When was Kodak Digital Sciences (KDS) Image View cleared by the FDA?
Kodak Digital Sciences (KDS) Image View (K981053) received a 510(k) decision of Substantially Equivalent on June 18, 1998, 87 days after the submission was received.
What is the product code of K981053?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.