Identity
- Trade Name
- MicroDose SI FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Philips MicroDose SI (Model: L50) is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems. FDA UDI
- Model / Reference
- L50 FDA UDI
- Description
- Philips MicroDose SI (Model: L50) is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems. FDA UDI
Identifiers
- Catalog Number
- 714248 FDA UDI
- Primary DI / UDI-DI
- 00884838071001 FDA UDI
- FDA Product Code
- MUE FDA UDI
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1715 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
No
FDA UDI
Category: Stationary mammographic x-ray system, digital
MicroDose SI by Philips Digital Mammography Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Philips Digital Mammography Sweden AB
Sources (1)
- FDA UDI 988c3386-8732-4f7e-97ba-7ebdb8ce7645 34 fields · synced May 30, 2026