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510(k) K212186

Philips Radiology Smart Assistant by Philips Medical Systems Dmc GmbH — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2021
Date Received
July 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K173433 — ProxiDiagnost N90 (February 5, 2018)

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