K190575 is an FDA 510(k) clearance for the iBreastExam. This device is classified as a System, Documentation, Breast Lesion (Class II - Special Controls, product code NKA).
Submitted by Ue Lifesciences, Inc. (Philadelphia, US). The FDA issued a Cleared decision on July 16, 2019, 132 days after receiving the submission on March 6, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2990. A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam..
| 510(k) Number | K190575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2019 |
| Decision Date | July 16, 2019 |
| Days to Decision | 132 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NKA - System, Documentation, Breast Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2990 |
| Definition | A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam. |