Home GUDID 00852619008041
QT Scanner 2000
Primary DI 00852619008041
Brand QT Scanner 2000
Company Qt Imaging, Inc.
Model Model B
Catalog number 100950
Device description The QT Scanner 2000 Model B is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator. The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. The QT Scanner 2000 Model B is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
Published 2026-06-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic IYO System, Imaging, Pulsed Echo, Ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00852619008041 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00852619008041 00852619008041 852619008041 0852619008041
GMDN Terms# Term, Definition table Term Definition General-purpose ultrasound imaging system A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
Regulatory Flags# DUNS number 035528118 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00852619008003 QT Scanner 2000 A 100366 2022-09-28
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841517112653 rP19x/5-1 MHz Armored FUJIFILM SONOSITE, INC. ITX 2026-06-24 00841517112653 rP19x/5-1 MHz Armored FUJIFILM SONOSITE, INC. IYO 2026-06-24 00841517112660 L12-3 FUJIFILM SONOSITE, INC. IYO 2026-06-24 00841517112660 L12-3 FUJIFILM SONOSITE, INC. ITX 2026-06-24 00841517112677 L15-4 FUJIFILM SONOSITE, INC. IYO 2026-06-24 00841517112677 L15-4 FUJIFILM SONOSITE, INC. ITX 2026-06-24 00841517112646 L15-4 FUJIFILM SONOSITE, INC. ITX 2026-06-23 00841517112646 L15-4 FUJIFILM SONOSITE, INC. IYO 2026-06-23 00841517112639 L12-3 FUJIFILM SONOSITE, INC. IYO 2026-06-22 00841517112639 L12-3 FUJIFILM SONOSITE, INC. ITX 2026-06-22 00198953078716 LOGIQ GE Medical Systems (China) Co.,Ltd. ITX 2026-06-10 00198953078716 LOGIQ GE Medical Systems (China) Co.,Ltd. IYO 2026-06-10 00198953078747 LOGIQ GE Medical Systems (China) Co.,Ltd. IYO 2026-06-10 00198953078754 LOGIQ GE Medical Systems (China) Co.,Ltd. ITX 2026-06-10 00198953078754 LOGIQ GE Medical Systems (China) Co.,Ltd. IYO 2026-06-10 00198953147009 LOGIQ GE Medical Systems (China) Co.,Ltd. ITX 2026-06-10 00198953147009 LOGIQ GE Medical Systems (China) Co.,Ltd. IYO 2026-06-10 00198953147016 LOGIQ GE Medical Systems (China) Co.,Ltd. ITX 2026-06-10 00198953147016 LOGIQ GE Medical Systems (China) Co.,Ltd. IYO 2026-06-10 00198953147351 LOGIQ GE Medical Systems (China) Co.,Ltd. IYO 2026-06-10 00198953147351 LOGIQ GE Medical Systems (China) Co.,Ltd. ITX 2026-06-10 00850050934233 EndoSound® EVS Probe Endosound, Inc. ITX 2026-06-01 00850050934240 EndoSound® EVS SideBeam 5103 Endosound, Inc. IYO 2026-06-01 00850050934257 EndoSound® Coax Transducer Extension Connector (TEC) Endosound, Inc. IYO 2026-06-01 00850050934264 EndoSound® EVS SideBeam 5105 (4 pouches) Endosound, Inc. IYO 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYO 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYO 2026-06-01 08800013510112 L8-17H Alpinion Medical Systems Co., Ltd. IYO 2026-05-29