Axxent Electronic Brachytherapy System Model 110 XP 1200
FDA 510(k) K153570 · Icad, Inc.
510(k) numberK153570
Submission
- Device name
- Axxent Electronic Brachytherapy System Model 110 XP 1200
- Applicant
- Icad, Inc.
Nashua, NH, US - Received
- December 14, 2015
- Decision date
- February 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Axxent Electronic Brachytherapy System Model 110 XP 1200 cleared by the FDA?
Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) received a 510(k) decision of Substantially Equivalent on February 25, 2016, 73 days after the submission was received.
What is the product code of K153570?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.