Identity
- Trade Name
- CONVEX ARRAY TRANSDUCER FDA UDI
- Generic Name
- Surgical ultrasound imaging transducer FDA UDI
- Device Name
- CONVEX ARRAY TRANSDUCER FDA UDI
- Model / Reference
- PVM-787LA FDA UDI
- Description
- CONVEX ARRAY TRANSDUCER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670001680 FDA UDI
- 510(k) Number
- K061605 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Surgical ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
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
Category: Surgical ultrasound imaging transducer
Convex Array Transducer by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HUMANSCAN — Humanscan Company, Ltd. · Class II
Cleared under the same submission
K061605 also covers:
- CONVEX ARRAY PROBE — Canon Medical Systems Corporation
- CONVEX ARRAY TRANSDUCER — Canon Medical Systems Corporation
- CONVEX ARRAY TRANSDUCER — Canon Medical Systems Corporation
- CONVEX ARRAY TRANSDUCER — Canon Medical Systems Corporation
- CONVEX ARRAY TRANSDUCER — Canon Medical Systems Corporation
- CONVEX ARRAY TRANSDUCER — Canon Medical Systems Corporation
- CW DOPPLER PENCIL TRANSDUCER — Canon Medical Systems Corporation
- DOPPLER PENCIL PROBE — Canon Medical Systems Corporation
- ENDOCAVITARY TRANSDUCER — Canon Medical Systems Corporation
- ENDOCAVITARY TRANSDUCER — Canon Medical Systems Corporation
- ENDOCAVITARY TRANSDUCER — Canon Medical Systems Corporation
- ENDOVAGINAL TRANSDUCER — Canon Medical Systems Corporation
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
- Canon Medical Systems Corporation
Sources (1)
- FDA UDI 98fabfdb-07ef-45fd-9225-bafe5955a805 35 fields · synced May 30, 2026