# K013428: Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Apr 4, 2002 after 170 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 K954276 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981686: Stealthstation System Digitizer Change, Surgical Navigation Technologies, Inc. (1998) Summary page 1.
- K003699: Medivision Igs System, Medivision (U.S.A.), Inc. (2001) Summary page 1.
- K001153: Modification to Steathstation Treatment Guidance Platform, Medtronic Surgical Navigation (2000) Summary page 1.
- K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent, Brainlab AG (2001). Our OCR of the scanned summary read K005389, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “VectorVision®”.

## Most influential descendants
- K041897: Mayfield Acciss II Image Guided Surgery System, Model 2002-01 (2005), 0 descendants of its own

## Indications for use
The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

Source page: https://510kreport.com/device/K013428
Methodology: https://510kreport.com/methodology