# K992843: The Mayfield / Acciss System with Windows NT for Cranial Surgery, the Mayfield / Optical Acciss System with Windows NT F

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Nov 2, 1999 after 70 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: 3 generations back to K851659 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K982244: Mayfield Acciss Optical System, Ohio Medical Instrument Co., Inc. (1998) Summary page 1.

## Indications for use
The MAYFIELD® ACCISS™ Operating Arm System with Windows NT® for Cranial Surgery and the MAYFIELD®/Optical ACCISS™ System (OASYS™) with Windows NT® for Cranial Surgery and with Wireless Probe/Dynamic Reference Frame are indicated for use in guidance and localization in open craniotomies, and for surgeries that are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies, and electrode implants. The Systems may also be used to review medical images in a neurosurgical context.

Source page: https://510kreport.com/device/K992843
Methodology: https://510kreport.com/methodology