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510(k) K251992

ArmSure Fluoroscopic Positioning System by Savfe Co. , Ltd. — Product Code OWB

K251992 is an FDA 510(k) premarket notification submitted by Savfe Co. , Ltd. for the device "ArmSure Fluoroscopic Positioning System". The FDA issued a decision of Substantially Equivalent on February 11, 2026. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2026
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances for product code OWB

  • K253670 — SmartCT (R3.0 (L10)) (July 10, 2026)
  • K252735 — C-beam (May 22, 2026)
  • K252503 — Intelligent NR (April 30, 2026)
  • K254173 — ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (April 24, 2026)
  • K253752 — ARTIS genio floor; ARTIS icono.explore floor (April 23, 2026)
  • K252229 — BELLIGER ACE (April 2, 2026)
  • K252099 — Trinias (March 24, 2026)
  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)

FDA data resources