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 the device name listed in this FDA 510(k) record. The listed applicant is QT Imaging Holdings, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) 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. The listed applicant is QT Imaging Holdings, Inc.. The 510(k) number is K253898.

When did QT Scanner 2000 Model A receive FDA 510(k) clearance?

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

Who is the listed applicant for QT Scanner 2000 Model A?

The FDA 510(k) record lists QT Imaging Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: IYO)

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.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited

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.