Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009717300

FEI Number

3009717300

Entity Name

iCRco Inc.

City/State/Country

Goleta, CA, US

Establishment Address

26 Coromar Dr, Goleta, CA 93117, US

Establishment Type(s)

Repack or Relabel Medical Device,Remanufacture Medical Device,Manufacture Medical Device

Owner / Operator

ICRCO INC. (Owner Number: 9022417)

Owner / Operator Contact Address

26 Coromar Drive, --, Goleta, CA 93117, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122510

PMA Number

N/A

All Registered Proprietary Names

XC 1.18 AirDR AirDR ClarityPractice iXRS AirDR G3 AirDR Claris XT iDR 3600M ClarityPACS 3600LF ClarityPractice ClarityPACS ClarityPACS AirDR-M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2005-10-28
LMA	Digitizer, Image, Radiological	Radiology	Class 2	892.2030	2001-10-29
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2020-06-02
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2014-06-03
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2026-03-17
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-06-15
LMA	Digitizer, Image, Radiological	Radiology	Class 2	892.2030	2008-04-16
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2014-06-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-01-24
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2013-05-06

Official Correspondent

STEPHEN NEUSHUL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICRCO 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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009717300. Last updated year: 2026. Please use registration number 3009717300 when referencing this establishment in official correspondence.