FDA.report

510(k) K250241

Device
Cios Select
Applicant
Siemens Medical Solutions USA, Inc.
510(k) number
K250241
Product code
OWB
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-04
Date received
2025-01-27
Regulation
892.1650
Classification name
Interventional Fluoroscopic X-Ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Patricia D. Jones
Address
40 Liberty Blvd. Malvern PA US 19355 19355

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation2025-10-10
K251523Cios SpinSiemens Medical Solutions USA, Inc.2025-07-29