SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface
FDA premarket approval P200040/S001 · decided 2024-04-11
Approval details
- PMA number
- P200040
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface
- Generic name
- Automated breast ultrasound
- Applicant
- Delphinus Medical Technologies
- Date received
- 2023-05-30
- Decision date
- 2024-04-11
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Novi, MI
- Statement
- Approval for a manufacturing site change to Delphinus Medical Technologies, Inc., 45525 Grand River Ave, Suite 100, Novi, MI 48374-1308.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SoftVue (K172256) | Delphinus Medical Technologies | 2018-03-02 |