iBreastExam
FDA 510(k) clearance K142926 · decided 2015-04-23
Clearance details
- K-number
- K142926
- Device name
- iBreastExam
- Applicant
- Ue Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-08
- Decision date
- 2015-04-23
- Days to decision
- 197 days
- Clearance type
- Abbreviated
- Product code
- NKA
- Device class
- 2
- Regulation number
- 884.2990
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iBreastExam (K190575) | Ue Lifesciences, Inc. | 2019-07-16 |
| SureTouch Mobile Pressure Mapping System (K181672) | Sure, Inc. | 2019-06-28 |
| BREASTVIEW VISUAL MAPPING SYSTEM (DEN020001) | Assurance Medical | 2003-01-31 |
Recalls involving this device
No recalls on record reference this clearance.