Identity
- Trade Name
- BIOPSY ADAPTOR FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- UAGV-034A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670100987 FDA UDI
- 510(k) Number
- K233195 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable 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: Ultrasound imaging system tracking positioner, reusable
Biopsy Adaptor by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound imaging system tracking positioner, reusable.
- Multi Angle Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Needle Guide Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- NGB-025 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Reusable Biopsy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Reusable Multi Angle Biospy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
Cleared under the same submission
K233195 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
- BIOPSY ADAPTOR — Canon Medical Systems Corporation
- BIOPSY ADAPTOR — Canon Medical Systems Corporation
- LINEAR 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 eeeff7c1-1a5b-4aed-ab9a-2cc82f9897f1 33 fields · synced Jun 1, 2026