Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SM-V

K-Number: K222951 · 2022-11-21

ApplicantSedecal., Sa.
Decision Date2022-11-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SM-V is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2022-11-21 under approval number K222951. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SM-V?

SM-V is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Sedecal., Sa.. The 510(k) number is K222951.

When was SM-V approved by the FDA?

SM-V received FDA 510(k) clearance on 2022-11-21, under approval number K222951.

What company makes SM-V?

SM-V is manufactured by Sedecal., Sa..

What is the FDA product code for SM-V?

The FDA product code for SM-V is IZL.

Other Devices by Sedecal., Sa.

K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR K173299DRAGON X SPSL4HC, DRAGON X SPSL8HC K192936Soltus 500 K192011PhoeniX K191813MobileDiagnost wDR 2.2 K202293Radiographic System Challenge X

View all 11 devices →

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑