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

FDA 510(k)

BEAMSCAN

K-Number: K161807 · 2017-05-19

Decision Date2017-05-19
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEAMSCAN is a medical device manufactured by Ptw-Freiburg Physikalisch Technische-Werksraetten. It received FDA 510(k) clearance on 2017-05-19 under approval number K161807. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAMSCAN?

BEAMSCAN is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Ptw-Freiburg Physikalisch Technische-Werksraetten. The 510(k) number is K161807.

When was BEAMSCAN approved by the FDA?

BEAMSCAN received FDA 510(k) clearance on 2017-05-19, under approval number K161807.

What company makes BEAMSCAN?

BEAMSCAN is manufactured by Ptw-Freiburg Physikalisch Technische-Werksraetten.

What is the FDA product code for BEAMSCAN?

The FDA product code for BEAMSCAN is IYE.

Related Devices (Code: IYE)

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.