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FDA 510(k)

breastscape v1.0

K-Number: K211431 · 2021-08-02

ApplicantOlea Medical
Decision Date2021-08-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

breastscape v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K211431. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the breastscape v1.0?

breastscape v1.0 is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Olea Medical. The 510(k) number is K211431.

When did breastscape v1.0 receive FDA 510(k) clearance?

breastscape v1.0 received FDA 510(k) clearance on 2021-08-02, under 510(k) number K211431.

Who is the listed applicant for breastscape v1.0?

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

What is the FDA product code for breastscape v1.0?

The FDA product code for breastscape v1.0 is QIH.

Other records listing Olea Medical 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.

K223091CT Perfusion V1.0K223532Olea S.I.A. Neurovascular V1.0K230552MR DWI/FLAIR Measurement V1.0K223502MR Diffusion Perfusion Mismatch V1.0K152602Olea Sphere V3.0

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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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