Home GUDID 00850008977473 PowerLook Al Mammo Container- Blackford v1.0.0
Primary DI 00850008977473
Brand PowerLook Al Mammo Container- Blackford v1.0.0
Company Icad, Inc.
Model DSC036-01
Published 2023-07-14
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 LMD System, Digital Image Communications, Radiological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LMD System, Digital Image Communications, Radiological Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850008977473 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 00850008977473 00850008977473 850008977473 0850008977473
GMDN Terms# Term, Definition table Term Definition Radiology DICOM image processing application software A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).
Regulatory Flags# DUNS number 108870254 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true 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 00850008977176 ProFound AI V3.0 3.0 2021-05-17 00850008977183 PowerLook AMP with Density Assessment GE US DSC012-02 2021-05-17 00850008977190 PowerLook AMP with Density Assessment GE OUS DSC012-03 2021-05-17 00858012005090 PowerLook AMP SLD GE OUS DSC010-01-EU 2021-05-17 00858012005106 PowerLook AMP SLD GE OUS Direct DSC010-12-EU 2021-05-17 00858012005113 PowerLook AMP SLD Siemens OUS DSC010-03-EU 2021-05-17 00858012005120 PowerLook AMP SLD Fuji OUS DSC010-04-EU 2021-05-17 00858012005137 PowerLook AMP SLD Hologic OUS DSC010-05-EU 2021-05-17 00858012005144 PowerLook AMP SLD Giotto DSC010-06 2021-05-17 00858012005151 PowerLook AMP SLD Philips OUS DSC010-07-EU 2021-05-17 00858012005168 PowerLook AMP SLD Planmed DSC010-08 2021-05-17 00858012005175 PowerLook AMP SLD Agfa CR DSC010-09 2021-05-17 00858012005236 PowerLook PRO Tomo Detection and SLD, GE V1.1 DSC014-01-EU 2021-05-17 00858012005250 PowerLook PRO Tomo Detection and SLD, GE V1.1 DSC014-02-EU 2021-05-17 00858012005809 Powerlook PRO Hardware Upgrade, SLD V7.2 DSC017-02-ROW 2021-05-17 00858012005823 Powerlook PRO Hardware Upgrade, SLD V7.2 DSC017-03-ROW 2021-05-17 00858012005830 PowerLook AMP PRO, SLD, GE, ROW V7.2 DSC017-01-ROW 2021-05-17 00858012005847 PowerLook AMP PRO, SLD, GE, ROW V7.2 DSC017-04-ROW 2021-05-17 00858012005960 ProFound AI 2.1 2019-07-11 00858012005007 SecondLook Digital (SLD) V7.2 DS0206 2014-09-22
Other Devices Sharing Product Codes#