BioTraceIO Vision (V1.7)
K-Number: K251931 · 2025-09-08
ApplicantTechsomed Medical Technologies
Decision Date2025-09-08
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BioTraceIO Vision (V1.7) is a medical device manufactured by Techsomed Medical Technologies. It received FDA 510(k) clearance on 2025-09-08 under approval number K251931. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioTraceIO Vision (V1.7)?
BioTraceIO Vision (V1.7) is a medical device that received FDA 510(k) clearance on 2025-09-08. It is manufactured by Techsomed Medical Technologies. The 510(k) number is K251931.
When was BioTraceIO Vision (V1.7) approved by the FDA?
BioTraceIO Vision (V1.7) received FDA 510(k) clearance on 2025-09-08, under approval number K251931.
What company makes BioTraceIO Vision (V1.7)?
BioTraceIO Vision (V1.7) is manufactured by Techsomed Medical Technologies.
What is the FDA product code for BioTraceIO Vision (V1.7)?
The FDA product code for BioTraceIO Vision (V1.7) is QTZ.
Related Devices (Code: QTZ)
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.