Chrysalis Intelligence · Sponsors · Orthoscan, Inc.

Orthoscan, Inc.

Scottsdale, AZ, US · 1 510(k) clearances · 7 recalls

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Total clearances
1
2021-10-21 → 2021-10-21
Last 12 months
0
Product codes
1
Most recent
2021-10-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Class II Radiology 1 2021-10-21
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
7
Most recent
2024-08-08
DateSeverityStatusRecall # ProductCodeReason
2024-08-08 Class II Ongoing Z-0579-2025 Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601…
2024-08-08 Class II Ongoing Z-0578-2025 Ziehm Vision RFD. Interventional fluoroscopic x-ray system — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601…
2024-08-08 Class II Ongoing Z-0577-2025 Ziehm Vision R. Iterventional fluoroscopic x-ray system — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601…
2024-08-08 Class II Ongoing Z-0576-2025 Ziehm Vision FD. Interventional fluoroscopic x-ray system — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601…
2024-08-08 Class II Ongoing Z-0575-2025 Ziehm Vision system, x-ray, tomography, computed. — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601…
2024-08-08 Class II Ongoing Z-0574-2025 Ziehm Solo FD. Interventional fluoroscopic x-ray system — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601…
2024-08-08 Class II Ongoing Z-0573-2025 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…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-10-21 K213113 Orthoscan Tau Mini C-Arm OXO Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence