Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000V
FDA 510(k) K112054 · Toshiba Medical Systems Corporation, Japan
510(k) numberK112054
Submission
- Device name
- Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000V
- Applicant
- Toshiba Medical Systems Corporation, Japan
Tustin, CA, US - Received
- July 19, 2011
- Decision date
- August 5, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000V cleared by the FDA?
Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000V (K112054) received a 510(k) decision of Substantially Equivalent on August 5, 2011, 17 days after the submission was received.
What is the product code of K112054?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.