Home / 510(k) Clearances / K935580

510(k) K935580

PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER by Precise Optics — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
November 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Fluoroscopy of the human body.

Other clearances by Precise Optics

  • K030061 — PS 3000 DIGATAL PHOTOSPOT SYSTEM (April 7, 2003)
  • K932878 — PRECISION INTRA-ORAL SCOPES (January 6, 1994)
  • K914084 — ENDOSCOPES (January 22, 1992)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE (July 26, 1991)
  • K903459 — PRECISION OPTICS ENDOSCOPE ADAPTER (October 26, 1990)
  • K903458 — PRECISION OPTICS IMAGE COUPLER (October 19, 1990)
  • K903457 — PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) (October 19, 1990)
  • K820178 — PI808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)
  • K827087 — P1808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)

Other clearances for product code OXO

  • K252579 — Orthoscan TAU MVP Mini C-Arm System (January 14, 2026)
  • K253269 — OEC One CFD (November 26, 2025)
  • K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (November 6, 2025)
  • K250587 — Orthoscan TAU Mini C-Arm (July 2, 2025)
  • K243452 — Orthoscan VERSA Mini C-Arm (January 14, 2025)
  • K240828 — OEC One ASD (December 27, 2024)
  • K233669 — OEC 3D (March 28, 2024)
  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K203346 — OEC 3D (March 5, 2021)
  • K192819 — OEC Elite (November 8, 2019)