Identity
- Trade Name
- Faxitron Core Specimen Radiography System EUDAMEDFAXITRON CORE FDA UDI
- Generic Name
- Tissue specimen x-ray system IVD FDA UDI
- Device Name
- Faxitron Radiography System EUDAMEDCabinet x-ray device used to generate x-ray of specimens from various anatomical regions FDA UDI
- Model / Reference
- COREVISION5X10 EUDAMEDCOREVISION 5X10 FDA UDI
- Description
- Cabinet x-ray device used to generate x-ray of specimens from various anatomical regions FDA UDI
Identifiers
- Catalog Number
- COREVISION5X10 FDA UDI
- Primary DI / UDI-DI
- 15420045514218 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455FAXITRONCABXRAYBU EUDAMED
- Direct Marketing DI
- 15420045514218 EUDAMED
- 510(k) Number
- K082432 FDA UDI
- FDA Product Code
- MWP FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
- GMDN Term
- Tissue specimen x-ray system IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Tissue specimen x-ray system IVD
Faxitron Core by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K082432 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI 951b5f34-13ee-4e08-8e85-4309a7860a96 37 fields · synced Jun 18, 2026
- EUDAMED e3193e4d-b38a-419a-b94c-ddc3a9844fad 61 fields · synced Jun 18, 2026