# K982244: Mayfield Acciss Optical System

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Sep 23, 1998 after 90 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: 2 generations back to K851659 (1985). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955397: Mayfield-Acciss Workstation, Nomos Corp. (1996) Summary page 1.
- K874833: Arc Adapter Assembly, Medical Equipment Development Co., Inc. (1988) Summary page 1.

## Most influential descendants
- K992843: The Mayfield / Acciss System with Windows NT for Cranial Surgery, the Mayfield / Optical Acciss System with Windows NT F (1999), 0 descendants of its own
- K991267: Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss Systems Module, Mayfield/Acciss Spine Ring a (1999), 0 descendants of its own

## Indications for use
Intended Use: The Optical Tracking ACCISS™ System is intended to be used in an identical manner as the predicate device (Mayfield®/ ACCISS™ Stereotactic Workstation). It is used for guidance and localization in open craniotomies and for surgeries, which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.

Source page: https://510kreport.com/device/K982244
Methodology: https://510kreport.com/methodology