The Mayfield / Acciss System with Windows Nt for Cranial Surgery, the Mayfield / Optical Acciss System with Windows Nt F
by Ohio Medical Instrument Co., Inc.
510(k) K992843
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992843 | Date2 Nov 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Mayfield/Acciss System With Windows NT for Cranial Surgery is a stereotactic surgical system designed for cranial procedures, combining mechanical arm support with optical tracking to enhance precision during open craniotomies and stereotactic interventions. It integrates a retractable operating arm and a dynamic reference frame to facilitate accurate localization and guidance of surgical instruments in neurosurgical applications.
This system is supplied as a reusable medical device and is intended for use in operating room environments. It requires compatibility with MRI-safe settings as specified in its design, and its components are engineered for repeated use under sterile conditions. The device holds an FDA 510(k) clearance under K992843, classified as a Class II medical device, with a decision of Substantially Equivalent to a predicate device. No additional regulatory markings or sterility claims are provided in the specifications.
Other devices from Ohio Medical Instrument Co., Inc.
Questions
AI-generated answers, 19 Sep 2026
Is this system reusable or single-use, and how should it be handled between procedures to maintain sterility?
The Mayfield/Acciss System is designed for reusable use in operating room environments. Since it is intended for repeated use, it must be thoroughly cleaned, disinfected, and sterilized between procedures to ensure sterility. The manufacturer recommends following standard surgical instrument reprocessing protocols to maintain safe, sterile conditions for subsequent cranial surgeries.
What types of cranial procedures is this system specifically designed to assist with?
This system combines a mechanical arm support and optical tracking to enhance precision during open craniotomies and stereotactic interventions. It is particularly useful for procedures requiring accurate localization and guidance of surgical instruments, such as biopsies, deep brain stimulator placements, or other neurosurgical applications where spatial precision is critical.
Does this device require any special environmental considerations, such as MRI compatibility?
Yes, the Mayfield/Acciss System is designed with MRI-safe components as part of its specifications. This means it can be used in operating rooms where MRI imaging may be performed, provided the system’s design guidelines for MRI compatibility are followed. Always verify compatibility with your facility’s MRI protocols before use.
How is this system different from traditional Mayfield cranial fixation systems?
Unlike traditional Mayfield cranial fixation systems, which rely solely on mechanical clamping for stability, the Mayfield/Acciss System integrates optical tracking with a retractable operating arm and a dynamic reference frame. This hybrid approach provides enhanced precision and real-time guidance for surgical instruments, making it ideal for stereotactic procedures where spatial accuracy is paramount.