Identity
- Trade Name
- ADD FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger. FDA UDI
- Model / Reference
- HAD1717MCW FDA UDI
- Description
- The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger. FDA UDI
Identifiers
- Catalog Number
- HAD1717MCW FDA UDI
- Primary DI / UDI-DI
- 08800070400050 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Indirect flat panel x-ray detector
Add by H&abyz Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- H&abyz Co., Ltd.
Sources (1)
- FDA UDI 6eb46f27-8bee-4610-8229-163ca21263f8 35 fields · synced Jun 1, 2026