Identifiers
- 510(k) Number
- K950317 FDA 510(k)
- FDA Product Code
- IXL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1670 FDA 510(k)
- Regulation Number
- 892.1670 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Advantx 1824 Spotfilm Device is a spot-film device used in radiology. It is designed to facilitate radiographic imaging procedures.
This device is classified as a Class II medical device under regulation number 892.1670. It received FDA 510(k) clearance under K950317.
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: ADVANTX 1824 SPOTFILM DEVICE (K950317) - FDA 510 (k), ADVANTX 1824 SPOTFILM DEVICE (K950317) — FDA 510(k) | Innolitics, PDF K950317 - Advantx 1824 Spotfilm Device, GE Advantx 1824 Spotfilm - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950317 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K950317 24 fields · synced Oct 6, 2026