Optiview
FDA 510(k) K972520 · Optimed Technologies, Inc.
510(k) numberK972520
Submission
- Device name
- Optiview
- Applicant
- Optimed Technologies, Inc.
Livingston, NJ, US - Received
- July 7, 1997
- Decision date
- September 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Optiview cleared by the FDA?
Optiview (K972520) received a 510(k) decision of Substantially Equivalent on September 29, 1997, 84 days after the submission was received.
What is the product code of K972520?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.