FDA.reportPublic FDA data

CYCLE CLARITY

Matched from indexed company URL: Cycle Clarity, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30249724253024972425CYCLE CLARITY1N2026-01-011209 Fifteen Mile Landing Rd. Awendaw SC US 29429

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008194435Cycle Clarity - 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.843-883-6200support@cycleclarity.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3109961659530931K212012Follicle ClarityQIH2022-01-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH12022-01-19

PMN#

GUDID#