Home GUDID 07290019208075 UltraSight Guidance
Primary DI 07290019208075
Brand UltraSight Guidance
Company ULTRASIGHT LTD
Model V1
Published 2026-05-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290019208075 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290019208075 07290019208075 7290019208075
GMDN Terms# Term, Definition table Term Definition Ultrasound imaging system application software An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
Regulatory Flags# DUNS number 521106393 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290019208402 PVAD IQ V1 2026-05-13 07290019208068 UltraSight Guidance V2 2026-04-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290019208068 UltraSight Guidance ULTRASIGHT LTD QJU 2026-04-20 00198953038604 Caption GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC QJU 2025-09-15 00198953030233 Caption GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC QJU 2025-07-28 00860003586341 Caption AI (Caption Guidance + Caption Interpretation) CAPTION HEALTH, INC. QJU 2024-04-01 00860003586334 Caption Guidance CAPTION HEALTH, INC. QJU 2023-09-30 00860003586310 Caption AI (Caption Guidance + Caption Interpretation) CAPTION HEALTH, INC. QJU 2022-03-15 00860003586303 Caption AI (Caption Guidance + Caption Interpretation) CAPTION HEALTH, INC. QJU 2020-06-05
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