Cleared Traditional

Radiography 7300 C

K233662 · Philips Medical Systems Dmc GmbH · Radiology
Jun 2024
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K233662 is an FDA 510(k) clearance for the Radiography 7300 C, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on June 13, 2024, 211 days after receiving the submission on November 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K233662 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2023
Decision Date June 13, 2024
Days to Decision 211 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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