LungMaps— 510(k) K253690
Substantially EquivalentSiemens Healthineers AG
FDA 510(k) clearance K253690 for LungMaps, Substantially Equivalent on 2026-06-15. Applicant: Siemens Healthineers AG. Device class: 2.
Summary
Siemens Healthineers' LungMaps is filed under QIH, automated radiological image processing software. The name points to lung images, but the record doesn't describe the processing it performs or its outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Siemens Healthineers filed from Forchheim, Germany. The decision came 206 calendar days after FDA received it (November 21, 2025 to June 15, 2026).
Clearance details
- Applicant
- Siemens Healthineers AG
- Product code
- Product 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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