Data / Medical devices / United States / Orthoscan, Inc.

Orthoscan, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 8 510(k) clearances

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

Orthoscan, Inc. is registered with the FDA (registration 3005254598) in Scottsdale, AZ, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 14, 2026. 2 recall events name it as the recalling firm. 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 Orthoscan, Inc.

FDA registration number: 3005254598
Address: 14555 N. 82nd Street, Scottsdale, AZ, United States, 85260
Owner or operator: Ziehm-Orthoscan INC. (9073005)
Roles: Complaint file establishment, Manufacturer
First device listed: November 9, 2007
Registered through: 2026
Brand names listed: OrthoScan EMR Image Link, OrthoScan FD Mini C-arm, OrthoScan HD, OrthoScan Mobile DI, Orthoscan TAU MVP Mini C-arm System, Orthoscan TAU Mini C-arm, Orthoscan VERSA Mini C-Arm, TAU Model 1000-0015 Mini C-Arm and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Complaint file establishment, 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
January 14, 2026	K252579	Orthoscan TAU MVP Mini C-Arm System	OXO	Substantially Equivalent	Ziehm-Orthoscan, Inc.	accessdata.fda.gov
July 2, 2025	K250587	Orthoscan TAU Mini C-Arm	OXO	Substantially Equivalent	Ziehm-Orthoscan, Inc.	accessdata.fda.gov
January 14, 2025	K243452	Orthoscan VERSA Mini C-Arm	OXO	Substantially Equivalent	Ziehm-Orthoscan, Inc.	accessdata.fda.gov
October 21, 2021	K213113	Orthoscan Tau Mini C-Arm	OXO	Substantially Equivalent	Orthoscan, Inc.	accessdata.fda.gov
June 21, 2019	K183220	OrthoScan TAU Mini C-Arm	OXO	Substantially Equivalent	Orthoscan, Inc.	accessdata.fda.gov
March 28, 2014	K133174	ORTHOSCAN FD MINI C-ARM	OXO	Substantially Equivalent	Orthoscan, Inc.	accessdata.fda.gov
January 5, 2012	K113708	ORTHOSCAN MOBILE DI MINI C-ARM	OXO	Substantially Equivalent	Orthoscan, Inc.	accessdata.fda.gov
August 9, 2005	K051754	ORTHOSCAN, ORTHOSCAN HD	OXO	Substantially Equivalent	Orthoscan, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 8, 2024	95709	Class II	Ongoing	Ziehm Solo. Digital Mobile C-arm	Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching elemen	accessdata.fda.gov
August 31, 2017	78784	Class II	Terminated	Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergenc	OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user	accessdata.fda.gov

Compare with other makers

Updated January 14, 2026. 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.