FDA UDI
In Commercial Distribution
🇺🇸 United States
Horizon C
DI: 15420045505698
·
Model: Horizon C
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Horizon C
- Primary DI
- 15420045505698
- Version / Model
- Horizon C
- Catalog Number
- Horizon-C
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 153623137
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 6
- Public Version Date
- 2024-04-19
- Public Version Status
- Update
- Public Device Record Key
- 521ecbfb-d030-4375-8bf1-1f3d4833bbb0
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGI | Densitometer, bone | Radiology | 892.1170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37661 | Bone absorptiometric x-ray system, dual-energy | An assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045505698 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023398 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity