Identifiers
- 510(k) Number
- K131483 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Philips Pixium 4343RC is a wireless flat panel detector designed for digital radiography. It is used to capture high-quality images in medical imaging applications, particularly in embolization procedures. The device is a Class II X-ray system that provides images of equivalent diagnostic capability compared to predicate systems.
The Pixium 4343RC is supplied as a single-use device and is not MRI compatible. It is stored at room temperature and requires FDA 510(k) clearance for use in radiology procedures. The device has been cleared by the FDA with product code MQB and regulation number 892.1680.
Frequently asked questions
What is the Philips Pixium 4343RC used for?
The Philips Pixium 4343RC is a wireless flat panel detector designed for digital radiography, specifically used to capture high-quality images in medical imaging applications, particularly in embolization procedures.
Is the Pixium 4343RC a single-use device?
Yes, the Pixium 4343RC is supplied as a single-use device and is not intended for reuse. It should be discarded after a single procedure to ensure optimal performance and safety.
What are the storage requirements for the Pixium 4343RC?
The Pixium 4343RC should be stored at room temperature. Proper storage conditions help maintain the device's functionality and image quality until it is ready for use in radiology procedures.
What regulatory clearance does the Pixium 4343RC have?
The Pixium 4343RC has received FDA 510(k) clearance with product code MQB and regulation number 892.1680. It is classified as a Class II X-ray system and has been determined to be substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips Dmc Pixium 4343RC - allmed.wiki, PHILIPS PIXIUM 4343RC (K131483) — FDA 510 (k) | Innolitics, Philips Pixium 4343RC - Philips Medical Systems Dmc | FDA Evidence Review, PDF K131483 - Philips Pixium 4343rc, Global home | Philips
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131483 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
Sources (1)
- FDA 510(k) K131483 24 fields · synced Sep 24, 2026