# K955397: Mayfield-Acciss Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Nomos Corp.
- Decided: Apr 30, 1996 after 158 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 K851659 (1985). 3 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911783: Allegro Viewing Wand, I.S.G. Technologies, Inc. (1994) Summary page 1.
- K851659: Skull Mounted Stereotactic Surgical Device, Medco Products, Co., Inc. (1985) Summary page 1.
- K915791: Coritaxic Multi-Modal Stereotaxi  Workstation, Coritechs, Inc. (1992) Summary page 1.

## Most influential descendants
- K981424: Nomos Bat Ultrasound Localization and Positioning System (1998), 10 descendants of its own
- K032100: I-BEAM (2003), 4 descendants of its own
- K042110: Beamcath (2005), 3 descendants of its own
- K041937: Restitu (2004), 3 descendants of its own
- K111332: Clarity Obp System (2012), 2 descendants of its own

## Indications for use
ACCISS is to be used both 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/K955397
Methodology: https://510kreport.com/methodology