CRW-1 SYSTEM— 510(k) K944463

Clearance details

Applicant

Radionics Software Applications, Inc.

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

1994-09-12

Decision date

1995-10-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burlington, MA, US

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
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• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K990326 — OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII1999-03-04
• K974602 — OPTICAL TRACKING SYSTEM (OTS)1998-04-21
• K972905 — XPLAN-11997-10-28
• K964801 — OPTICAL TRACKING SYSTEM (OTS)1997-06-02
• K961844 — OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]1996-10-23

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-0025-2016 — Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.Class II·Terminated·Integra LifeSciences Corp.·20150821
• Z-2428-2012 — Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodesClass II·Terminated·Integra LifeSciences Corporation·20120809
• Z-2429-2012 — Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodesClass II·Terminated·Integra LifeSciences Corporation·20120809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944463.