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Advanced Algorithms for Treatment Management Applications (AATMA)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212218

by Elekta Solutions Ab

Identifiers

510(k) Number
K212218 FDA 510(k)
FDA Product Code
QKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Advanced Algorithms for Treatment Management Applications (AATMA) by Elekta Solutions Ab — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Elekta Solutions Ab

Sources (1)

  • FDA 510(k) K212218 24 fields · synced Jun 18, 2026