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510(k) K242512

ROCC Console by Philips Medical Systems Nederland B.V. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2024
Date Received
August 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR (June 4, 2025)

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