Infinix-i, INFX-8000V, V7.0
FDA 510(k) K172863 · Toshibamedical Systems Corporation
510(k) numberK172863
Submission
- Device name
- Infinix-i, INFX-8000V, V7.0
- Applicant
- Toshibamedical Systems Corporation
Otawara-Shi, JP - Received
- September 20, 2017
- Decision date
- December 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Infinix-i, INFX-8000V, V7.0 cleared by the FDA?
Infinix-i, INFX-8000V, V7.0 (K172863) received a 510(k) decision of Substantially Equivalent on December 14, 2017, 85 days after the submission was received.
What is the product code of K172863?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.