Cleared Special

CombiDiagnost R90

K232910 · Philips Medical Systems Dmc GmbH · Radiology
Oct 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K232910 is an FDA 510(k) clearance for the CombiDiagnost R90, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on October 19, 2023, 30 days after receiving the submission on September 19, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K232910 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2023
Decision Date October 19, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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