# K253690: LungMaps

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthineers AG
- Decided: Jun 15, 2026 after 206 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K971684 (1997). 192 ancestors in all.
No later device cites it as a predicate yet.
5 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182904: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2019) Summary page 6.

## Indications for use
LungMaps is a post-processing software application for supporting the evaluation of lung perfusion and ventilation based on Magnetic Resonance Imaging (MRI). The software can be used for the creation of maps and statistical evaluations providing information on lung perfusion and ventilation. Results when interpreted by a radiologist yield information that may assist in diagnosis. The results shall not be used as only source for diagnosis. LungMaps is intended for patients aged 6 years and older who require evaluation of lung perfusion and/or ventilation.

Source page: https://510kreport.com/device/K253690
Methodology: https://510kreport.com/methodology