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510(k) K233945

ProxiDiagnost N90 / Precision CRF (706110, 706400) by Philips Medical Systems Dmc GmbH — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2024
Date Received
December 14, 2023
Clearance Type
Special
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

Other clearances by Philips Medical Systems Dmc GmbH

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  • K212186 — Philips Radiology Smart Assistant (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)
  • K210692 — DigitalDiagnost (April 2, 2021)
  • K203087 — CombiDiagnost R90 (December 3, 2020)
  • K202564 — DigitalDiagnost C90 (September 30, 2020)
  • K182973 — DigitalDiagnost C90 (January 11, 2019)
  • K173433 — ProxiDiagnost N90 (February 5, 2018)

Other clearances for product code JAA

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  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 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)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)
  • K212145 — DR 800 with DSA, DR 800 (August 31, 2021)