Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029302

FEI Number

1000306472

Entity Name

CliniSys, Inc

City/State/Country

TUCSON, AZ, US

Establishment Address

3300 E. Sunrise Dr., TUCSON, AZ 85718, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CliniSys, Inc (Owner Number: 9010587)

Owner / Operator Contact Address

3300 E. Sunrise Dr., Tucson, AZ 85718, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clinisys Atlas® Clinisys SQ Lab Clinisys Laboratory Solution (Core) Clinisys CoPathPlus® Clinisys VUE Clinical Clinisys PowerPath®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2001-01-16
NVV	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System	Clinical Chemistry	Class 1	862.2100	2007-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CliniSys, Inc

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
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029302. Last updated year: 2026. Please use registration number 2029302 when referencing this establishment in official correspondence.