Identity
- Trade Name
- B-scan Plus Software Package: Veterinary Version FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Model / Reference
- 1.03.03-U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00897826002192 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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: Ophthalmic ultrasound imaging system
B-scan Plus Software Package: Veterinary Version by Accutome, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic ultrasound imaging system.
- A-scan probe — Nidek, Inc. · Class II
- ArcScan Insight 100 — Arcscan, Inc. · Class II
- Ultrasonic A/B Scanner for Ophthalmology — Meda , Ltd. · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
- Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
- A-scan probe — Nidek, Inc. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Accutome, Inc.
Sources (1)
- FDA UDI e993d83f-e778-433c-b1f0-c07764423f9a 32 fields · synced May 31, 2026