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)

MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT

K-Number: K130885 · 2013-05-17

Decision Date2013-05-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K130885. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT?

MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K130885.

When did MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT receive FDA 510(k) clearance?

MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT received FDA 510(k) clearance on 2013-05-17, under 510(k) number K130885.

Who is the listed applicant for MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT?

The FDA product code for MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT is LNH.

Related Clinical Trials

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.

Other records listing Siemens Medical Solutions USA, Inc. 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.

View all 732 devices →

Related Devices (Code: LNH)

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.

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.

↑