Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020436 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
- Models / Variants
- Portable X-Ray Units FDA 510(k)Models Sp-Hf-2.8 & Sp-Hf-4.0 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)
This device is a portable X-ray unit, specifically models SP-HF-2.8 and SP-HF-4.0, designed for mobile radiographic imaging. It is classified as a Class II medical device under FDA regulation 892.1720 and is substantially equivalent to a legally marketed predicate device.
The unit is manufactured by Sedecal., Sa. and received FDA 510(k) clearance (K020436) on February 22, 2002. It is intended for use in radiology settings and is supplied as a non-sterile, reusable system. No information regarding sterility, single-use status, MRI safety, specific sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance is provided in the data.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020436 | Class II | Active |
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Manufacturer
- Manufacturer
- Sedecal., Sa.
Sources (1)
- FDA 510(k) K020436 24 fields · synced Sep 21, 2026