Identity
- Trade Name
- 2020 Imaging Podiatry System HF FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- X-Ray System, Podiatry DR Ready (70kVp,10mA). FDA UDI
- Model / Reference
- XR410i FDA UDI
- Description
- X-Ray System, Podiatry DR Ready (70kVp,10mA). FDA UDI
Identifiers
- Catalog Number
- PXS-710 FDA UDI
- Primary DI / UDI-DI
- 00817100020148 FDA UDI
- 510(k) Number
- K133959 FDA UDI
- FDA Product Code
- KPR FDA UDIMQB FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
2020 Imaging Podiatry System HF by Konica Minolta Medical Imaging U.s.a., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133959 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
- Konica Minolta Medical Imaging U.s.a., Inc.
Sources (1)
- FDA UDI b1a0df74-6c0d-490a-88f7-cb645e4180b5 36 fields · synced Jun 8, 2026