Identity
- Trade Name
- ENDOCAVITARY TRANSDUCER FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- ENDOCAVITARY TRANSDUCER FDA UDI
- Model / Reference
- PVT-661VT FDA UDI
- Description
- ENDOCAVITARY TRANSDUCER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670001864 FDA UDI
- 510(k) Number
- K151451 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Rectal/vaginal 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: Rectal/vaginal ultrasound imaging transducer
Endocavitary Transducer by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151451 also covers:
- BIOPSY ADAPTOR — Canon Medical Systems Corporation
- BIOPSY ADAPTOR — Canon Medical Systems Corporation
- BIOPSY ADAPTOR — Canon Medical Systems Corporation
- BIOPSY ADAPTOR — Canon Medical Systems Corporation
- BIOPSY ADAPTOR — 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
- CONVEX ARRAY TRANSDUCER — Canon Medical Systems Corporation
- CONVEX ARRAY 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Canon Medical Systems Corporation
Sources (1)
- FDA UDI a66ceb4a-29f7-4eec-86dd-8590baacfe42 35 fields · synced Jun 1, 2026