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510(k) K893617

MOBILE C-ARM by Acoma Medical Imaging, Inc. — Product Code OXO

K893617 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "MOBILE C-ARM". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
May 10, 1989
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 Acoma Medical Imaging, Inc.

  • K981227 — SYMPHONY 360 REMOTE CONTROL TABLE (June 30, 1998)
  • K981131 — PATHFINDER MOBILE C ARM (June 26, 1998)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K944952 — ANGIOGRAPHIC SYSTEM (February 17, 1995)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (February 1, 1993)
  • K921116 — PX-100 PORTABLE X-RAY GENERATOR (October 5, 1992)
  • K921425 — SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R (August 27, 1992)
  • K902637 — FUTURUS 2001 X-RAY GENERATOR (August 3, 1990)

Other clearances for product code OXO

  • K253296 — Digital C-ARM with 3D (June 5, 2026)
  • 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)

FDA data resources