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)

Solas OR

K-Number: K213691 · 2021-12-22

ApplicantCirdan Imaging, Ltd.
Decision Date2021-12-22
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Solas OR is a medical device manufactured by Cirdan Imaging, Ltd.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213691. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solas OR?

Solas OR is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Cirdan Imaging, Ltd.. The 510(k) number is K213691.

When was Solas OR approved by the FDA?

Solas OR received FDA 510(k) clearance on 2021-12-22, under approval number K213691.

What company makes Solas OR?

Solas OR is manufactured by Cirdan Imaging, Ltd..

What is the FDA product code for Solas OR?

The FDA product code for Solas OR is MWP.

Related Devices (Code: MWP)

K153583BioVision PlusFaxitron Bioptics, LLC K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC K173309Faxitron VisionCTFaxitron Bioptics, LLC K192939Volumetric Specimen ImagerClarix Imaging K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited K183624Kubtec Mozart (Xpert42)Kub Technologies, 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.

↑