Identity
- Trade Name
- MinXray FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, analogue FDA UDI
- Device Name
- This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a podiatric mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors FDA UDI
- Model / Reference
- HFP24 Podiatric X-ray unit FDA UDI
- Description
- This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a podiatric mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858846007246 FDA UDI
- 510(k) Number
- K060566 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Portable basic diagnostic x-ray system, analogue FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 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: Portable basic diagnostic x-ray system, analogue
MinXray by Minxray, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Portable basic diagnostic x-ray system, analogue.
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- MinXray — Minxray, Inc. · Class II
Cleared under the same submission
K060566 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
- Minxray, Inc.
Sources (1)
- FDA UDI bbb7ba6a-2c6c-45d0-b43b-acf661d4c391 36 fields · synced Jun 8, 2026