AccessGUDID - DEVICE: ImageChecker CAD 10.0 (15420045500037)

GUDID

Device Identifier (DI) Information

Brand Name: ImageChecker CAD 10.0
Version or Model: 10.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R2LIC-2111
Company Name: Hologic, Inc.

Primary DI Number: 15420045500037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153623137 *Terms of Use

Device Description: ImageChecker® computer-aided detection is a software application intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57812	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 quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYN	Analyzer,medical image

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970058	026

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2e42487-d03b-4e9a-8c55-d91443427e39
Public Version Date: April 11, 2024
Public Version Number: 9
DI Record Publish Date: July 01, 2014