Identity
- Trade Name
- Biim Android App, P1.3 FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Biim Android App, P1.3 FDA UDI
- Model / Reference
- P001228 FDA UDI
- Description
- Biim Android App, P1.3 FDA UDI
Identifiers
- Catalog Number
- P001228 FDA UDI
- Primary DI / UDI-DI
- 07090045490198 FDA UDI
- 510(k) Number
- K173138 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDILLZ FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.2050 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-heldHand-held ultrasound imaging system, body-surface
Biim Android App, P1.3 by Biim Ultrasound AS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173138 also covers:
- Adapter Bracket, Biim Ultrasound — Biim Ultrasound AS
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS
- Battery Charger EU, Biim Ultrasound — Biim Ultrasound AS
- Battery Charger UK, Biim Ultrasound — Biim Ultrasound AS
- Battery Charger, Biim Ultrasound — Biim Ultrasound AS
- Battery, Biim Ultrasound — Biim Ultrasound AS
- Biim Android App, P1.1 — Biim Ultrasound AS
- Biim Android App, P1.2 — Biim Ultrasound AS
- Biim Android App, P1.3.1 — Biim Ultrasound AS
- Biim Android App, P1.3.2 — Biim Ultrasound AS
- Biim Android App, P2.0 — Biim Ultrasound AS
- Biim Ultrasound L12-4 Linear Array Transducer — Biim Ultrasound AS
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
- Biim Ultrasound AS
Sources (1)
- FDA UDI 82e51925-25ac-43cd-aa19-4239094e28c2 35 fields · synced May 30, 2026