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MAGIS1 - Magis1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061713

by Direx Systems Corp.

Identifiers

510(k) Number
K061713 FDA 510(k)
FDA Product Code
IYE FDA 510(k)
Models / Variants
Magis1 FDA 510(k)
magis2 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

MAGIS1 - Magis1 by Direx Systems Corp. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Direx Systems Corp.

Sources (1)

  • FDA 510(k) K061713 24 fields · synced Jun 18, 2026