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Lunar iDXA
FDA UDIClass II (US FDA UDI)
by Ge Medical Systems, Ultrasound & Primary Care Diagnostics, Llc
Identity
- Trade Name
- Lunar iDXA FDA UDI
- Generic Name
- Bone absorptiometric x-ray system, dual-energy FDA UDI
- Model / Reference
- F1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682117029 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
Lunar iDXA by Ge Medical Systems, Ultrasound & Primary Care Diagnostics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133664 also covers:
K161682 also covers:
K191112 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
Sources (1)
- FDA UDI 02960696-3f38-4059-8b5e-3583ac8b3e2e 34 fields · synced Jun 8, 2026