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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Techsomed Medical Technologies. It received FDA 510(k) clearance on 2025-09-08 under 510(k) 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. The listed applicant is Techsomed Medical Technologies. The 510(k) number is K251931.

When did BioTraceIO Vision (V1.7) receive FDA 510(k) clearance?

BioTraceIO Vision (V1.7) received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251931.

Who is the listed applicant for BioTraceIO Vision (V1.7)?

The FDA 510(k) record lists Techsomed Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioTraceIO Vision (V1.7)?

The FDA product code for BioTraceIO Vision (V1.7) is QTZ.

Other records listing Techsomed Medical Technologies 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.

K243084BioTraceIO Precision (2.0)

Related Devices (Code: QTZ)

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.

K253264myAblation Guide (VC10A)Siemens Healthcare GmbHK252947HistoSonics® Planning ToolHistoSonics, Inc.K240796myAblation Guide (VB80A)Siemens Healthcare GmbHK240773VisAble.IOTechsomedK222222Artemis, Artemis TPO, Artemis MXEigenK222938Ablation-fitR.A.W. S.R.L

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.

↑