510(k) · Radiology

breastscape v1.0

by Olea Medical

breastscape v1.0 is an AI-enabled medical device from Olea Medical that the U.S. FDA cleared through 510(k) K211431 on August 2, 2021. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK211431
Pathway510(k)
Date of final decision
Company (FDA list)Olea Medical
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Olea Medical
Applicant locationLa Ciotat, FR
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. breastscape v1.0 went through this pathway (K211431).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #24 of 305 under that code. Olea Medical has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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