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)

VIZION

K-Number: K112276 · 2011-11-16

ApplicantTrek Diagnostic Systems
Decision Date2011-11-16
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIZION is the device name listed in this FDA 510(k) record. The listed applicant is Trek Diagnostic Systems. It received FDA 510(k) clearance on 2011-11-16 under 510(k) number K112276. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIZION?

VIZION is a medical device that received FDA 510(k) clearance on 2011-11-16. The listed applicant is Trek Diagnostic Systems. The 510(k) number is K112276.

When did VIZION receive FDA 510(k) clearance?

VIZION received FDA 510(k) clearance on 2011-11-16, under 510(k) number K112276.

Who is the listed applicant for VIZION?

The FDA 510(k) record lists Trek Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIZION?

The FDA product code for VIZION is JWY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trek Diagnostic Systems 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.

K111615SENSITITRE 18-24 HR SUSCEPTIBILITY PLATESK103532AUTOREADER 2K103456THE SENSITITRE AIM

Related Devices (Code: JWY)

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.

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SAK260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher ScientificK250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher ScientificK252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

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.

↑