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16ch Flex SPEEDER Medium 1.5T (Q7000246) +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K244054
Identifiers
- 510(k) Number
- K244054 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
- Models / Variants
- 16ch Flex SPEEDER Medium 1.5T (Q7000246) FDA 510(k)16ch Flex SPEEDER Large 1.5T (Q7000247) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
16ch Flex SPEEDER Medium 1.5T (Q7000246) +1 more model by Quality Electrodynamics — Class II — FDA_510K — listed in FDA 510(k) — 2 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K244054 | Class II | Active |
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Manufacturer
- Manufacturer
- Quality Electrodynamics
Sources (1)
- FDA 510(k) K244054 24 fields · synced Jun 18, 2026