BREASTVIEW VISUAL MAPPING SYSTEM
FDA 510(k) clearance DEN020001 · decided 2003-01-31
Clearance details
- K-number
- DEN020001
- Device name
- BREASTVIEW VISUAL MAPPING SYSTEM
- Applicant
- Assurance Medical
- Decision
- Unknown
- Date received
- 2002-05-28
- Decision date
- 2003-01-31
- Days to decision
- 248 days
- Clearance type
- Post-NSE
- Product code
- NKA
- Device class
- 2
- Regulation number
- 884.2990
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, 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 |
| iBreastExam (K142926) | Ue Lifesciences, Inc. | 2015-04-23 |
Recalls involving this device
No recalls on record reference this clearance.