Cleared Traditional

ROCC Console

K242512 · Philips Medical Systems Nederland B.V. · Radiology
Oct 2024
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K242512 is an FDA 510(k) clearance for the ROCC Console, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on October 24, 2024, 62 days after receiving the submission on August 23, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K242512 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2024
Decision Date October 24, 2024
Days to Decision 62 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050