Device
Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnosti...
Manufacturer
Cycle Clarity, LLC
Cycle Clarity, LLC
Model: 6.11.02
DI: 00860008194435
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnostic ultrasound systems. The software functions as an aid to interpreting clinicians by calculating the number and size of hypoechoic structures (ovarian follicles) in a transvaginal ultrasound volume sweep of the ovaries.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5c2ad986-0413-4a51-83d3-fc369dc4e3a1
Distribution Status:
In Commercial Distribution
DUNS Number:
117147273
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860008194435
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40873
Name: Ultrasound imaging system application software
Definition:
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.
FDA Product Codes
QIH
Automated Radiological Image Processing Software
Premarket Submissions
Submission Number:
K212012
Supplement Number:
000