FDA.reportPublic FDA data

Orthoscan TAU MVP 1515

Primary DI
B225100000220
Brand
Orthoscan TAU MVP 1515
Company
Ziehm-Orthoscan, Inc.
Model
1000-0022
Device description
Image-Intensified Fluoroscopic X-Ray, Mobile
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HRXArthroscope
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HRXArthroscopeOrthopedic2
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252579000Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.2026-01-14OXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B225100000220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Portable general-purpose fluoroscopic x-ray system, digitalA portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.

Contacts#

Phone, Email table
PhoneEmail
4805038010kevin.bridgman@ziehm-orthoscan.com

Regulatory Flags#

DUNS number
196554021
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B225100000230Orthoscan TAU MVP 20201000-00232026-04-30
B225100000200Orthoscan Versa Mini C-Arm1000-00202025-07-11
B225100000160TAU Model 1000-0016 Mini C-Arm1000-00162021-05-27
B225100000170TAU Model 1000-0017 Mini C-Arm1000-00172021-05-27
B225100000150TAU Model 1000-0015 Mini C-Arm1000-00152021-05-27
B225100000040OrthoScan HD Mini C-arm1000-00042017-03-07
B22510000004FD0OrthoScan Pulse Mini C-arm1000-0004-FD2017-03-07
B225100000050OrthoScan Mobile DI Mini C-arm1000-00052017-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18