Data / Medical devices / United States / iCRco Inc.

iCRco Inc.: FDA-registered device maker in Goleta, CA, United States, 10 510(k) clearances

Name: iCRco Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

iCRco Inc. is registered with the FDA (registration 3009717300) in Goleta, CA, United States. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 20, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch iCRco Inc.

FDA registration number: 3009717300
Address: 26 Coromar Dr, Goleta, CA, United States, 93117
Owner or operator: ICRCO INC. (9022417)
Roles: Manufacturer, Repackager or relabeler
First device listed: October 29, 2001
Registered through: 2026
Brand names listed: 3600 LF, 3600 SF, 3600M, AirDR G3, AirDR G3+, AirDR LE, AirDR-D, AirDR-P and more

Devices it lists

Device	Product code	Class	Role	Source
Assembly, Tube Housing, X-Ray, Diagnostic	ITY	1	Repackager or relabeler	accessdata.fda.gov
Camera, Multi Format, Radiological	LMC	2	Repackager or relabeler	accessdata.fda.gov
Device, Digital Image Storage, Radiological	LMB	1	Manufacturer	accessdata.fda.gov
Digitizer, Image, Radiological	LMA	2	Manufacturer	accessdata.fda.gov
Full Field Digital, System, X-Ray, Mammographic	MUE	2	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Repackager or relabeler	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 20, 2022	K221512	Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)	MQB	Substantially Equivalent	Vieworks Co., Ltd.	accessdata.fda.gov
June 10, 2020	K200976	SR-8230, SR-8230S Portable X-ray Unit	IZL	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)	accessdata.fda.gov
February 9, 2018	K173823	Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System	KPR	Substantially Equivalent	Summit Industries, LLC	accessdata.fda.gov
January 21, 2014	K132499	ICRCO CLARITY VIEWER	LLZ	Substantially Equivalent	Icrco, Inc.	accessdata.fda.gov
April 26, 2013	K122510	ICRCO 3600M	MUE	Substantially Equivalent	Icrco, Inc.	accessdata.fda.gov
July 26, 2012	K120753	CLARISCT	OAS	Substantially Equivalent	Icrco, Inc.	accessdata.fda.gov
June 14, 2012	K113449	FUSION FLAT PANEL	MQB	Substantially Equivalent	Icrco, Inc.	accessdata.fda.gov
June 30, 2009	K082450	IDR	MQB	Substantially Equivalent	Icrco, Inc.	accessdata.fda.gov
October 11, 2002	K022810	COBRASCAN CR-1 FILMLESS	LMA	Substantially Equivalent	Radiographic Digital Imaging, Inc.	accessdata.fda.gov
June 7, 2001	K002911	XSCAN32 TELERADIOLOGY SOFTWARE	LLZ	Substantially Equivalent	Radiographic Digital Imaging, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 20, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.