CYCLE CLARITY

FDA Device Registration & Listing · Awendaw, SC, US · Registration 3024972425

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024972425
FEI Number
3024972425
Entity Name
CYCLE CLARITY
City/State/Country
Awendaw, SC, US
Establishment Address
1209 Fifteen Mile Landing Rd., Awendaw, SC 29429, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Cycle Clarity (Owner Number: 10086465)
Owner / Operator Contact Address
1209 Fifteen Mile Landing Rd., Awendaw, SC 29429, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212012
PMA Number
N/A

All Registered Proprietary Names

Follicle Clarity

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-11-11

Official Correspondent

Chadd Clark

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cycle Clarity
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024972425. Last updated year: 2026. Please use registration number 3024972425 when referencing this establishment in official correspondence.
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