Data / Medical devices / United States / Accogent Pausch

Accogent Pausch: FDA-registered device maker in Eatontown, NJ, United States, 6 510(k) clearances

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

Accogent Pausch is registered with the FDA (registration 2243057) in Eatontown, NJ, United States. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 10, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2243057
Address: 6 Industrial Way W Ste C5, Eatontown, NJ, United States, 07724
Owner or operator: PAUSCH LLC (2243057)
Roles: Complaint file establishment, Manufacturer
First device listed: July 1, 1992
Registered through: 2026
Brand names listed: Bladeview, Bladeview HDR, Cirrus, CombiMax, CombiMax LH, CombiMax RH, ElevatorMax, FS 100 and more

Devices it lists

Device	Product code	Class	Role	Source
Collimator, Manual, Radiographic	IZX	2	Complaint file establishment	accessdata.fda.gov
Holder, Radiographic Cassette, Wall-Mounted	IXY	1	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomographic	IZF	2	Manufacturer	accessdata.fda.gov
Table, Cystometric, Electric	MMZ	2	Manufacturer	accessdata.fda.gov
Table, Cystometric, Non-Electric And Accessories	KQS	1	Manufacturer	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Manufacturer	accessdata.fda.gov
Table, Radiographic, Stationary Top	IXQ	2	Manufacturer	accessdata.fda.gov
Table, Radiographic, Tilting	IXR	2	Manufacturer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	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
August 10, 2011	K110856	RALCO	IZX	Substantially Equivalent	Ralco S.R.L.	accessdata.fda.gov
December 5, 2008	K081073	HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F	OWB	Substantially Equivalent	Pausch, LLC	accessdata.fda.gov
June 17, 1998	K973864	COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO	IZF	Substantially Equivalent	Pausch Corp.	accessdata.fda.gov
April 30, 1998	K973834	CS2000 & CS2000 TOMO	IZF	Substantially Equivalent	Pausch Corp.	accessdata.fda.gov
March 30, 1987	K870856	COSMOS	IYB	Substantially Equivalent	Pausch Corp.	accessdata.fda.gov
April 26, 1979	K790741	COMPACT SYSTEM	KPR	Substantially Equivalent	Pausch Corp.	accessdata.fda.gov

Compare with other makers

Updated August 10, 2011. 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.