Identity
- Trade Name
- Mammomat Inspiration FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- FFDM FDA UDI
- Model / Reference
- 10140000 FDA UDI
- Description
- FFDM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869009063 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
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: Stationary mammographic x-ray system, digital
Mammomat Inspiration by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary mammographic x-ray system, digital.
- Magnification table — FUJIFILM Corporation · Class II
- Compression plate for axilla radiography — FUJIFILM Corporation · Class II
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
- Senographe Pristina — GE MEDICAL SYSTEMS, INC. · Class II
- 3Dimensions — Hologic, Inc. · Class III
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia Dimensions — Hologic, Inc. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (1)
- FDA UDI c8f0c0f3-ee1c-4984-89f0-56f99f20e84b 34 fields · synced May 30, 2026