LungMaps— 510(k) K253690

Substantially Equivalent

Siemens Healthineers AG

FDA 510(k) clearance K253690 for LungMaps, Substantially Equivalent on 2026-06-15. Applicant: Siemens Healthineers AG. Device class: 2.

Clearance details

Applicant
Siemens Healthineers AG
Product code
Code QIH
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Forchheim, DE
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