Identity
- Trade Name
- Breast Imaging Accessory FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Model / Reference
- BIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850816007195 FDA UDI
- FDA Product Code
- IYX FDA UDI
- GMDN Term
- Radiological breast positioner, non-wearable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1100 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: Radiological breast positioner, non-wearable
Breast Imaging Accessory by Digirad Corp. — Class I — 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
- SenoView Prone Breast Board — Aktina Corp. · Class II
- MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
- Monarch™ Overhead Arm Positioner — Medtec LLC · Class II
- C-Qual™ — Medtec LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Digirad Corp.
Sources (1)
- FDA UDI 2d4830f0-1a5f-4a65-88ab-7f7d12778d1f 33 fields · synced May 30, 2026