Identity
- Trade Name
- SoftVue FDA UDI
- Generic Name
- Breast ultrasound imaging system FDA UDI
- Device Name
- SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly FDA UDI
- Model / Reference
- Atlantic FDA UDI
- Description
- SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly FDA UDI
Identifiers
- Catalog Number
- 900-00035 FDA UDI
- Primary DI / UDI-DI
- 00860000221306 FDA UDI
- PMA Number
- P200040 FDA UDI
- FDA Product Code
- PAA FDA UDI
- GMDN Term
- Breast ultrasound imaging system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast ultrasound imaging system
SoftVue by Delphinus Medical Technologies — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast ultrasound imaging system.
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- Invenia — GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Class III
- SonoCine Image Acquisition Station — Sonocine, Inc. · Class II
- Invenia — GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Class III
- ACUSON S2000 Automated Breast Volume Scanner — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Breast Volume Navigator (BVN) — Metritrack, Inc. · Class II
- SOFIA — IVU IMAGING CORPORATION · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Delphinus Medical Technologies
Sources (1)
- FDA UDI ad796bcb-7265-45c2-a0b0-a72e62706af6 37 fields · synced May 30, 2026