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510(k) K250241

Cios Select by Siemens Medical Solutions USA, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2025
Date Received
January 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 by Siemens Medical Solutions USA, Inc.

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  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K251481 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ul (August 20, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251523 — Cios Spin (July 29, 2025)
  • K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (July 28, 2025)
  • K251520 — Cios Alpha; Cios Flow (July 9, 2025)
  • K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (July 3, 2025)

Other clearances for product code OWB

  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)
  • K251523 — Cios Spin (July 29, 2025)