# K960907: ORCA

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: May 20, 1996 after 76 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
Longest line of descent: 1 generation back to K951765 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951765: Series 6600 Digital Mobile C-Arm, Ge Dec Medical Systems (1995) Summary page 1.

## Indications for use
The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA Operator’s manual contains the following statement: “CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician.”

Source page: https://510kreport.com/device/K960907
Methodology: https://510kreport.com/methodology