Identity
- Trade Name
- LODOX FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. FDA UDI
- Model / Reference
- eXero-dr FDA UDI
- Description
- The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. FDA UDI
Identifiers
- Catalog Number
- CL-08-0013-H4 FDA UDI
- Primary DI / UDI-DI
- 06009880828142 FDA UDI
- 510(k) Number
- K013999 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
No
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
Lodox by Lodox Systems (Pty), Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K013999 also covers:
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- LODOX — Lodox Systems (Pty), Ltd.
- Lodox — Lodox Systems (Pty), Ltd.
- Lodox — Lodox Systems (Pty), Ltd.
- Lodox — Lodox Systems (Pty), Ltd.
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
- Lodox Systems (Pty), Ltd.
Sources (1)
- FDA UDI e5b1ecf3-1606-4f89-858c-55862c27cc63 36 fields · synced May 30, 2026