Cleared Special

ProxiDiagnost N90 / Precision CRF (706110, 706400)

K233945 · Philips Medical Systems Dmc GmbH · Radiology
Jan 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K233945 is an FDA 510(k) clearance for the ProxiDiagnost N90 / Precision CRF (706110, 706400), 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 January 11, 2024, 28 days after receiving the submission on December 14, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K233945 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2023
Decision Date January 11, 2024
Days to Decision 28 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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