Home GUDID 00860014963704 Mammo Dx
Primary DI 00860014963704
Brand Mammo Dx
Company Deephealth, Inc.
Model 5.y.z
Published 2026-07-07
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 QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860014963704 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 00860014963704 00860014963704 860014963704 0860014963704
GMDN Terms# Term, Definition table Term Definition X-ray image interpretive software An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
Regulatory Flags# DUNS number 081336616 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08437021468243 QP-Prostate® CAD QUIBIM SOCIEDAD LIMITADA. QDQ 2026-06-05 08800076000230 Lunit INSIGHT DBT Lunit Inc. QDQ 2026-04-17 00850008977541 ProFound Detection Icad, Inc. QDQ 2026-03-23 08437021468236 QP-Prostate® CAD QUIBIM SOCIEDAD LIMITADA. QDQ 2026-03-06 08437021468168 QP-Prostate® CAD QUIBIM SOCIEDAD LIMITADA. QDQ 2025-05-02 08437021468120 QP-Prostate® CAD QUIBIM SOCIEDAD LIMITADA. QDQ 2025-03-28 08720387058051 Transpara Screenpoint Medical B.V. QDQ 2024-11-28 00860006305727 See-Mode Technologies SEE-MODE TECHNOLOGIES PTE. LTD. QDQ 2024-11-22 08800076000162 Lunit INSIGHT DBT Lunit Inc. QDQ 2024-04-09 08800076000148 Lunit INSIGHT DBT Lunit Inc. QDQ 2023-12-01 00860009082601 Bot Image, Inc. Bot Image, Inc. QDQ 2023-03-17 00860009082625 Bot Image, Inc. Bot Image, Inc. QDQ 2023-03-17 08720387058013 Transpara Screenpoint Medical B.V. QDQ 2023-03-03 00860009082618 Bot Image, Inc. Bot Image, Inc. QDQ 2023-01-11 00860005144013 Saige-Dx Deephealth, Inc. QDQ 2022-05-26 08800076000056 Lunit INSIGHT MMG Lunit Inc. QDQ 2022-04-28 B885MAML2US0 MammoScreen THERAPIXEL QDQ 2022-01-20 08719326450131 Transpara Screenpoint Medical B.V. QDQ 2021-07-23 00850008977176 ProFound AI V3.0 Icad, Inc. QDQ 2021-05-17 B885MAML0 MammoScreen THERAPIXEL QDQ 2020-06-23 08719326450117 Transpara Screenpoint Medical B.V. QDQ 2020-03-16 08719326450124 Transpara Screenpoint Medical B.V. QDQ 2019-12-12 00858012005960 ProFound AI Icad, Inc. QDQ 2019-07-11 08719326450100 Transpara Screenpoint Medical B.V. QDQ 2019-02-04 00858012005939 PowerLook Tomo Detection (ProFound AI) Icad, Inc. QDQ 2018-12-27