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Sign in to claim this brandWhat PIXXGEN Corporation makes
PIXXGEN Corporation manufactures indirect flat panel x-ray detectors, including models such as the PIXX1212, PIXX1417, PIXX1717, PIXX2430, and the ATAL 9 series. These devices are designed for use in medical imaging systems to capture high-resolution radiographic images, supporting applications in radiography and fluoroscopy.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. PIXXGEN Corporation is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does PIXXGEN Corporation manufacture?
PIXXGEN Corporation specializes in indirect flat panel x-ray detectors, which are critical components in medical imaging systems. These detectors convert x-ray energy into digital signals to produce high-resolution radiographic images, enabling applications in radiography and fluoroscopy. Examples of their products include models like the PIXX1212, PIXX1417, PIXX1717, PIXX2430, and the ATAL 9 series.
Where is PIXXGEN Corporation based?
PIXXGEN Corporation is headquartered in the United States. The company’s location is relevant for regulatory compliance, customer support, and distribution of its x-ray detector products.
Which regulatory registries list PIXXGEN Corporation’s devices?
PIXXGEN Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details like model names, manufacturers, and compliance information.
How are PIXXGEN Corporation’s devices classified under FDA regulations?
PIXXGEN Corporation’s indirect flat panel x-ray detectors are classified as Class II medical devices by the FDA. This classification indicates a moderate level of regulatory oversight, typically requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices are subject to performance standards or post-market surveillance to mitigate potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 557796065
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pixx1212 | PIXX1212 (Wired Detector) | FDA UDI | Class II | Active |
| Atal 9 | ATAL 9 (Battery Pack) | FDA UDI | Class II | Active |
| Pixx1417 | PIXX1417 (Wireless Detector) | FDA UDI | Class II | Active |
| Pixx1717 | PIXX1717 (Wired Detector) | FDA UDI | Class II | Active |
| Atal 9 | ATAL 9 (Wireless Detector) | FDA UDI | Class II | Active |
| Pixx1417 | PIXX1417 (Wired Detector) | FDA UDI | Class II | Active |
| Atal 9 | ATAL 9 (Portable Detector) | FDA UDI | Class II | Active |
| Pixx1717 | PIXX1717 (Wireless Detector) | FDA UDI | Class II | Active |
| Pixx1212 | PIXX1212 (Wireless Detector) | FDA UDI | Class II | Active |
| Atal 9 | ATAL 9 (Wired Detector) | FDA UDI | Class II | Active |
| Pixx2430 | PIXX2430 | FDA UDI | Class II | Active |
| Atal 9 | ATAL 9 (ATCB-9) | FDA UDI | Class II | Active |
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