Company ยท US
Orthoscan, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2021. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2021 | K213113 | Orthoscan Tau Mini C-Arm Orthoscan, Inc. | OXO |
| Jun 21, 2019 | K183220 | OrthoScan TAU Mini C-Arm Orthoscan, Inc. | OXO |
| Mar 28, 2014 | K133174 | ORTHOSCAN FD MINI C-ARM Orthoscan, Inc. | OXO |
| Jan 5, 2012 | K113708 | ORTHOSCAN MOBILE DI MINI C-ARM Orthoscan, Inc. | OXO |
| Aug 9, 2005 | K051754 | ORTHOSCAN, ORTHOSCAN HD Orthoscan, Inc. | OXO |
| Aug 28, 2001 | K011827 | ORTELIUS 800 Orthoscan , Ltd., IL | KQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system Open, Classified |
OWB | K231701 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision RFD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | K240099 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision R. Iterventional fluoroscopic x-ray system Open, Classified |
OWB | K061203 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision FD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | K240020 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision system, x-ray, tomography, computed. Open, Classified |
JAK | K073346 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Solo FD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | K234109 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Solo. Digital Mobile C-arm Open, Classified |
OWB | K092438 |
| Aug 31, 2017 | Orthoscan, Inc. Mobile Mini C-arm system Part # 1000-0004-FD.
Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures a Terminated |
OXO | K133174 |
| Aug 31, 2017 | Orthoscan, Inc. Mobile Mini C-arm system Part # 1000-0005.
Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and Terminated |
OXO | K113708 |
| Aug 31, 2017 | Orthoscan, Inc. Mobile Mini C-arm system Part # 1000-0004.
Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and Terminated |
OXO | K051754 |
| Aug 31, 2017 | Orthoscan, Inc. 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 Terminated |
OXO | K051754 |