Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LungMaps

K-Number: K253690 · 2026-06-15

ApplicantSiemens Healthineers AG
Decision Date2026-06-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LungMaps is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers AG. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253690. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungMaps?

LungMaps is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Siemens Healthineers AG. The 510(k) number is K253690.

When did LungMaps receive FDA 510(k) clearance?

LungMaps received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253690.

Who is the listed applicant for LungMaps?

The FDA 510(k) record lists Siemens Healthineers AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LungMaps?

The FDA product code for LungMaps is QIH.

Other records listing Siemens Healthineers AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureK253023BIOGRAPH OneK253495syngo.MR Applications (VB80)K251059Syngo Carbon Clinicals (VA41)K241898Symbia SPECT and SPECT/CT SystemsK183575ACUSON S3000, S2000 Diagnostic Ultrasound System

View all 7 devices →

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.K261349SwiftMRAirs Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑