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Cedars-Sinai Cardiac Suite Nuclear Medicine Software

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141652

by Cedars-Sinai Medical Center

Identifiers

510(k) Number
K141652 FDA 510(k)
FDA Product Code
KPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1200 FDA 510(k)
Regulation Number
892.1200 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Cedars-Sinai Cardiac Suite Nuclear Medicine Software by Cedars-Sinai Medical Center — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K141652 24 fields · synced Jun 18, 2026