Synerad Omni, Models AN6255 and AN6265
FDA 510(k) K071430 · Analogic Corp.
510(k) numberK071430
Submission
- Device name
- Synerad Omni, Models AN6255 and AN6265
- Applicant
- Analogic Corp.
Peabody, MA, US - Received
- May 23, 2007
- Decision date
- June 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Synerad Omni, Models AN6255 and AN6265 cleared by the FDA?
Synerad Omni, Models AN6255 and AN6265 (K071430) received a 510(k) decision of Substantially Equivalent on June 21, 2007, 29 days after the submission was received.
What is the product code of K071430?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.