Infinix INFX-8000V, V6.40

FDA 510(k) K170909 · Toshiba Medical Systems Coroporation

Substantially Equivalent

510(k) numberK170909

Submission

Device name
Infinix INFX-8000V, V6.40
Applicant
Toshiba Medical Systems Coroporation
Otawara-Shi, JP
Received
March 28, 2017
Decision date
June 16, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

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Questions and answers

When was Infinix INFX-8000V, V6.40 cleared by the FDA?

Infinix INFX-8000V, V6.40 (K170909) received a 510(k) decision of Substantially Equivalent on June 16, 2017, 80 days after the submission was received.

What is the product code of K170909?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.