FDA 510(k)

QT Scanner 2000 Model A

K-Number: K253898 · 2026-03-04

Decision Date2026-03-04

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QT Scanner 2000 Model A is a medical device manufactured by QT Imaging Holdings, Inc.. It received FDA 510(k) clearance on 2026-03-04 under approval number K253898. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QT Scanner 2000 Model A?

QT Scanner 2000 Model A is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by QT Imaging Holdings, Inc.. The 510(k) number is K253898.

When was QT Scanner 2000 Model A approved by the FDA?

QT Scanner 2000 Model A received FDA 510(k) clearance on 2026-03-04, under approval number K253898.

What company makes QT Scanner 2000 Model A?

QT Scanner 2000 Model A is manufactured by QT Imaging Holdings, Inc..

What is the FDA product code for QT Scanner 2000 Model A?

The FDA product code for QT Scanner 2000 Model A is IYO.

Related Clinical Trials

NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.