Dragon X SPSL4HC, Dragon X SPSL8HC
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173299 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dragon X SPSL4HC and Dragon X SPSL8HC are digital mobile diagnostic X-ray systems. These devices are designed to perform radiographic imaging procedures in a clinical setting.
These systems are classified as Class II medical devices under regulation number 892.1720 and have received FDA 510(k) clearance. They are identified by product code IZL and are manufactured by Sedecal, Sa. in Algete, Spain.
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: DRAGON X SPSL4HC, DRAGON X SPSL8HC (K173299) — FDA 510 (k) | Innolitics, DRAGON X SPSL4HC, DRAGON X SPSL8HC (K173299) - FDA 510(k), PDF SEDECAL S. - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173299 | Class II | Active |
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Manufacturer
- Manufacturer
- Sedecal., Sa.
Sources (1)
- FDA 510(k) K173299 24 fields · synced Sep 23, 2026