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

FDA 510(k)

ClearRead Xray Pneumothorax

K-Number: K213566 · 2022-03-10

ApplicantRiverain Technologies, Inc.
Decision Date2022-03-10
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearRead Xray Pneumothorax is the device name listed in this FDA 510(k) record. The listed applicant is Riverain Technologies, Inc.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213566. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearRead Xray Pneumothorax?

ClearRead Xray Pneumothorax is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Riverain Technologies, Inc.. The 510(k) number is K213566.

When did ClearRead Xray Pneumothorax receive FDA 510(k) clearance?

ClearRead Xray Pneumothorax received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213566.

Who is the listed applicant for ClearRead Xray Pneumothorax?

The FDA 510(k) record lists Riverain Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearRead Xray Pneumothorax?

The FDA product code for ClearRead Xray Pneumothorax is QFM.

Other records listing Riverain Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242188ClearRead CT CACK221612ClearRead CTK161201ClearRead CT

Related Devices (Code: QFM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-AiK243808Rayvolve PTX-PEAZmedK243548BriefCase-TriageAidoc Medical , Ltd.

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.

↑