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510(k) K212837

ProxiDiagnost N90 by Philips Medical Systems Dmc GmbH — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2021
Date Received
September 7, 2021
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

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  • K212186 — Philips Radiology Smart Assistant (December 13, 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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  • 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)
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  • K212145 — DR 800 with DSA, DR 800 (August 31, 2021)