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510(k) K163210

Philips CombiDiagnost R90 by Philips Medical Systems Dmc GmbH — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2017
Date Received
November 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • K210692 — DigitalDiagnost (April 2, 2021)
  • K203087 — CombiDiagnost R90 (December 3, 2020)
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  • K182973 — DigitalDiagnost C90 (January 11, 2019)

Other clearances for product code JAA

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  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
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