AccessGUDID - DEVICE: ClariSIGMAM (08800046800013)

GUDID

Device Identifier (DI) Information

Brand Name: ClariSIGMAM
Version or Model: 1.1.7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ClariPI Inc.

Primary DI Number: 08800046800013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 693744312 *Terms of Use

Device Description: ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.

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
QIH	Automated Radiological Image Processing Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203785	000

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: 7b12f818-d08d-4f48-bbca-52d0ea495232
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2023