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FDA 510(k)

BriefCase, RIB Fractures Triage (RibFx)

K-Number: K202992 · 2021-04-14

ApplicantAidoc Medical , Ltd.
Decision Date2021-04-14
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BriefCase, RIB Fractures Triage (RibFx) is the device name listed in this FDA 510(k) record. The listed applicant is Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K202992. 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 BriefCase, RIB Fractures Triage (RibFx)?

BriefCase, RIB Fractures Triage (RibFx) is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Aidoc Medical , Ltd.. The 510(k) number is K202992.

When did BriefCase, RIB Fractures Triage (RibFx) receive FDA 510(k) clearance?

BriefCase, RIB Fractures Triage (RibFx) received FDA 510(k) clearance on 2021-04-14, under 510(k) number K202992.

Who is the listed applicant for BriefCase, RIB Fractures Triage (RibFx)?

The FDA 510(k) record lists Aidoc Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BriefCase, RIB Fractures Triage (RibFx)?

The FDA product code for BriefCase, RIB Fractures Triage (RibFx) is QFM.

Other records listing Aidoc Medical , Ltd. 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.

K261317BriefCase-TriageK253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceK251195BriefCase-TriageK252970BriefCase-Triage: CARE Multi-triage CT BodyK253265BriefCase-TriageK251406BriefCase-Triage

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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.

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