Edge Air (1417) Digital Flat Panel X-ray Detector
FDA 510(k)Class II (US FDA 510(k))
by Osko, Inc.
Identifiers
- 510(k) Number
- K201503 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 Edge Air (1417) is a solid state X-ray imager designed for digital radiography systems. It functions as a digital flat panel detector that captures X-ray images and converts them into digital signals using a scintillator coupled to an a-Si TFT.
This device is available in both wired and wireless configurations for use in clinical settings. It is regulated under FDA 510(k) clearance as a class 2 medical device.
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: OSKO EDGE AIR 1417 USER & SERVICE MANUAL Pdf Download, Osko Edge Air 1417 Manuals | ManualsLib, Osko Edge Air 1417WCC User & Service Manual | Manualzz, Edge Air (1417) Digital Flat Panel X-ray Detector
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201503 | Class II | Active |
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Manufacturer
- Manufacturer
- Osko, Inc.
Sources (1)
- FDA 510(k) K201503 24 fields · synced Sep 24, 2026