Orthoscan, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
6
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0577-2025Class IIZiehm Vision R. Iterventional fluoroscopic x-ray systemAugust 8, 2024
Z-0576-2025Class IIZiehm Vision FD. Interventional fluoroscopic x-ray systemAugust 8, 2024
Z-0574-2025Class IIZiehm Solo FD. Interventional fluoroscopic x-ray systemAugust 8, 2024
Z-0578-2025Class IIZiehm Vision RFD. Interventional fluoroscopic x-ray systemAugust 8, 2024
Z-0579-2025Class IIZiehm Vision RFD 3D. Interventinoal fluoroscopic x-ray systemAugust 8, 2024
Z-0575-2025Class IIZiehm Vision system, x-ray, tomography, computed.August 8, 2024
Z-0573-2025Class IIZiehm Solo. Digital Mobile C-armAugust 8, 2024
Z-0258-2018Class IIMobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroAugust 31, 2017
Z-0261-2018Class IIMobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoAugust 31, 2017
Z-0259-2018Class IIMobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroAugust 31, 2017
Z-0260-2018Class IIMobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroAugust 31, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K213113Orthoscan Tau Mini C-ArmOctober 21, 2021
K183220OrthoScan TAU Mini C-ArmJune 21, 2019
K133174ORTHOSCAN FD MINI C-ARMMarch 28, 2014
K113708ORTHOSCAN MOBILE DI MINI C-ARMJanuary 5, 2012
K051754ORTHOSCAN, ORTHOSCAN HDAugust 9, 2005
K011827ORTELIUS 800August 28, 2001