Identity
- Trade Name
- SenoView Prone Breast Board FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Model / Reference
- 70-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365701000 FDA UDI
- 510(k) Number
- K991546 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological breast positioner, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological breast positioner, non-wearable
SenoView Prone Breast Board by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological breast positioner, non-wearable.
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- C-Qual™ — Medtec LLC · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Positioning Cushion — Medtec LLC · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Monarch™ Overhead Arm Positioner — Medtec LLC · Class II
- C-Qual™ — Medtec LLC · Class II
- Quest™ — Qfix · Class II
Cleared under the same submission
K991546 also covers:
- Adjustable Knee Support — Aktina Corp.
- Arm Cradle — Aktina Corp.
- Arm Positioning Kit — Aktina Corp.
- Arm Support, Dual Adjust, Elekta Compatible — Aktina Corp.
- Arm Support, Dual Adjust, Siemens Compatible — Aktina Corp.
- Arm Support, Single Adjust, Elekta Compatible — Aktina Corp.
- Arm Support, Vertical Adjust, Siemens Compatible — Aktina Corp.
- ArmCradle — Aktina Corp.
- ArmCradle2 — Aktina Corp.
- ArmCradle3 — Aktina Corp.
- ArmCradle4 — Aktina Corp.
- Axion 1 Carbon Fiber Breast Board — Aktina Corp.
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
- Aktina Corp.
Sources (1)
- FDA UDI 2c278817-d485-475b-9955-35dbc49ca3c1 33 fields · synced Jun 8, 2026