Home / 510(k) Clearances / K232910

510(k) K232910

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2023
Date Received
September 19, 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

  • K233662 — Radiography 7300 C (June 13, 2024)
  • K233678 — Radiography 7000 M (February 14, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • 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

  • K251650 — Insight Enhanced™ DRF (EN-1002-01) (September 16, 2025)
  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • 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)