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)

SafeCT-29

K-Number: K153331 · 2016-05-17

Decision Date2016-05-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SafeCT-29 is a medical device manufactured by Medic Vision Imaging Solutions. It received FDA 510(k) clearance on 2016-05-17 under approval number K153331. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeCT-29?

SafeCT-29 is a medical device that received FDA 510(k) clearance on 2016-05-17. It is manufactured by Medic Vision Imaging Solutions. The 510(k) number is K153331.

When was SafeCT-29 approved by the FDA?

SafeCT-29 received FDA 510(k) clearance on 2016-05-17, under approval number K153331.

What company makes SafeCT-29?

SafeCT-29 is manufactured by Medic Vision Imaging Solutions.

What is the FDA product code for SafeCT-29?

The FDA product code for SafeCT-29 is JAK.

Related Devices (Code: JAK)

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.