Identity
- Trade Name
- Horizon C FDA UDI
- Generic Name
- Bone absorptiometric x-ray system, dual-energy FDA UDI
- Device Name
- The Horizon® Dual-Energy X-Ray Absorptiometry (DXA) System is a computer-assisted X-Ray scanner used to aid a physician in measuring bone mineral density (BMD), determining fracture risk, and estimating the lean body mass and fat mass of non-osseous tissues. FDA UDI
- Model / Reference
- Horizon C FDA UDI
- Description
- The Horizon® Dual-Energy X-Ray Absorptiometry (DXA) System is a computer-assisted X-Ray scanner used to aid a physician in measuring bone mineral density (BMD), determining fracture risk, and estimating the lean body mass and fat mass of non-osseous tissues. FDA UDI
Identifiers
- Catalog Number
- Horizon-C FDA UDI
- Primary DI / UDI-DI
- 15420045505698 FDA UDI
- 510(k) Number
- K023398 FDA UDI
- FDA Product Code
- KGI FDA UDI
- GMDN Term
- Bone absorptiometric x-ray system, dual-energy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1170 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: Bone absorptiometric x-ray system, dual-energy
Horizon C by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023398 also covers:
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
- Hologic, Inc.
Sources (1)
- FDA UDI 521ecbfb-d030-4375-8bf1-1f3d4833bbb0 37 fields · synced May 30, 2026