Full Frame Zoom System
FDA 510(k) K961193 · Xre Corp.
510(k) numberK961193
Submission
- Device name
- Full Frame Zoom System
- Applicant
- Xre Corp.
Littleton, MA, US - Received
- March 21, 1996
- Decision date
- June 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Full Frame Zoom System cleared by the FDA?
Full Frame Zoom System (K961193) received a 510(k) decision of Substantially Equivalent on June 17, 1996, 88 days after the submission was received.
What is the product code of K961193?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.