Identity
- Trade Name
- Novasight Hybrid™ PIM FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Imaging System FDA UDI
- Model / Reference
- TA-07-0002 FDA UDI
- Description
- Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628055603092 FDA UDI
- 510(k) Number
- K172258 FDA UDI
- FDA Product Code
- OBJ FDA UDINQQ FDA UDIIYO FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Novasight Hybrid™ PIM by Conavi Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172258 also covers:
- Novasight Hybrid™ Catheter — Conavi Medical Inc
- Novasight Hybrid™ Catheter — Conavi Medical Inc
- Novasight Hybrid™ Catheter Accessories Package — Conavi Medical Inc
- Novasight Hybrid™ Catheter PIM Bag — Conavi Medical Inc
- Novasight Hybrid™ Hummingbird Console — Conavi Medical Inc
- Novasight Hybrid™ PIM — Conavi Medical Inc
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 II | Pending data |
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Manufacturer
- Manufacturer
- Conavi Medical Inc
Sources (1)
- FDA UDI c3bd20ed-bba2-426b-8462-9265913e29e6 36 fields · synced May 30, 2026