STEALTHSTATION TREATMENT GUIDANCE PLATFORM— 510(k) K992927

Clearance details

Applicant

Surgical Navigation Technologies, Inc.

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

1999-08-31

Decision date

1999-12-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Broomfield, CO, US

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
• K261932 — Leksell® Vantage Stereotactic System2026-08-05
• K253663 — Zeta Navigation System2026-05-01
• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K000246 — RADIOCAMERAS EXTRACRANIAL SYSTEM2000-10-20
• K994355 — RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION2000-03-22
• K992461 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM2000-02-22
• K993021 — METRX SYSTEM1999-11-10
• K992354 — SNT IMAGE ANALYSIS SYSTEM1999-10-12

Death

52

Injury

1,083

Malfunction

17,300

Total

18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2315-2016 — S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.Class II·Terminated·Medtronic Navigation, Inc.·20160718
• Z-1956-2013 — StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.Class II·Terminated·Medtronic Navigation, Inc.·20130715

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992927.