Identity
- Trade Name
- PIXX1417 FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. The digital signals are then read out by TFTs. FDA UDI
- Model / Reference
- PIXX1417 (Wireless Detector) FDA UDI
- Description
- Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. The digital signals are then read out by TFTs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809378240160 FDA UDI
- 510(k) Number
- K182533 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Indirect flat panel x-ray detector 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
No
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: Indirect flat panel x-ray detector
Pixx1417 by PIXXGEN Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DRX-1 Detector — CARESTREAM HEALTH, INC. · Class II
- P-75 — Konica Minolta, Inc. · Class II
- PEDRA — Radisen Co., Ltd. · Class II
Cleared under the same submission
K182533 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
- PIXXGEN Corporation
Sources (1)
- FDA UDI bda2b396-d324-48d3-b6fb-e5ccccc46d88 34 fields · synced May 30, 2026