K211431 is an FDA 510(k) clearance for the breastscape v1.0. This device is classified as a Automated Radiological Image Processing Software (Class II - Special Controls, product code QIH).
Submitted by Olea Medical (La Ciotat, FR). The FDA issued a Cleared decision on August 2, 2021, 87 days after receiving the submission on May 7, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code..
| 510(k) Number | K211431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2021 |
| Decision Date | August 02, 2021 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QIH - Automated Radiological Image Processing Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code. |