# K961844: Operating Arm System (Oas) [with CT and MR Images]

- Pathway: 510(k) (Traditional)
- Applicant: Radionics Software Applications, Inc.
- Decided: Oct 23, 1996 after 163 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K911783 (1994). 2 ancestors in all.
158 later devices descend from it; 3 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951262: Operating Arm System (Oas), Radionics Software Applications, Inc. (1995) Summary page 1.
- K911783: Allegro Viewing Wand, I.S.G. Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- K984298: Z Kat Flurotactic Guidance System Mki (1999), 152 descendants of its own
- K013025: Modification to Flourolab Plus (2001), 151 descendants of its own
- K031454: Acumen Surgical Navigation System (2004), 146 descendants of its own
- K031337: Acumen Surgical Navigation System (2003), 81 descendants of its own
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own

## Indications for use
OAS is a surgical planning system which enables the surgeon to plan a surgical procedure so as to optimize his approach. The OAS provides the surgeon with visual information to make assessments during a surgical procedure. OAS is indicated for the operative planning of surgical procedures, for example: tumor resection, ventricular shunt placement, craniotomy, and ENT-intranasal ethmoidectomy.

Source page: https://510kreport.com/device/K961844
Methodology: https://510kreport.com/methodology