# K926056: 9600 Fluoroscopic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Oec-Diasonics, Inc.
- Decided: Jan 21, 1993 after 51 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 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) Philips BV-29 Mobile C-Arm System: named in the summary without a submission number
- (no number) GE Stenoscop D6/D9 Mobile C-Arm System: named in the summary without a submission number
- (no number) Amerisys (Ziehm) ARIS C20 Mobile C-Arm System: named in the summary without a submission number
- (no number) Siemens Siremobil 2000 Mobile C-Arm System: named in the summary without a submission number
- (no number) Toshiba SXT-650A Mobile C-Arm System: named in the summary without a submission number
- (no number) Fischer Omni 325 Mobile C-Arm System: named in the summary without a submission number
- (no number) OEC-Diasonics Series 8000 Mobile C-Arm System: named in the summary without a submission number

## Most influential descendants
- K963093: Siremobil Compact (1996), 23 descendants of its own
- K040066: Siremobile C06 (2004), 21 descendants of its own
- K051133: Arcadis Avantic (2005), 20 descendants of its own
- K132094: Cios Alpha (2014), 19 descendants of its own
- K153244: Cios Fusion (2016), 15 descendants of its own

## Indications for use
The 8600 is designed to provide the physician with both fluoroscopic and radiographic (spot film) visualization of the patient. It can be used in surgical orthopedic, critical care, and emergency procedures, as well as cardiac and neurological applications. References made in this 510(k) summary to the radiographic mode apply to the use of a spot film device only.

Source page: https://510kreport.com/device/K926056
Methodology: https://510kreport.com/methodology