# K051754: Orthoscan, Orthoscan HD

- Pathway: 510(k) (Traditional)
- Applicant: Orthoscan, Inc.
- Decided: Aug 9, 2005 after 41 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE/OEC Medical Systems series 6800 mini view digital mobile imaging device: named in the summary without a submission number
- (no number) Hologic/FluoroScan Imaging System Premier Encore mobile imaging device: named in the summary without a submission number

## Most influential descendants
- K120388: Insight - FD Mini C-Arm Fluoroscopic Imaging System (2012), 0 descendants of its own

## Recalls of this device
- Aug 31, 2017 · Class II · Z-0258-2018: 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 
- Aug 31, 2017 · Class II · Z-0259-2018: 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 

## Indications for use
The OrthoScan mobile c-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to, surgical orthopedic procedures and critical and emergency care procedures. The intended users of this product are doctors surgeons, radiologists and technologists who will use this product in a hospital or clinical environment. It is anticipated that the majority of user will be orthopedic doctors, podiatrists and pediatricians, among others.

Source page: https://510kreport.com/device/K051754
Methodology: https://510kreport.com/methodology