Cleared Traditional

K944612 - ACUSTAR I ADVANCED SURGICAL NAVIGATION ...

K944612 is the FDA 510(k) clearance for ACUSTAR I ADVANCED SURGICAL NAVIGATION ... by Codman & Shurtleff, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K944612 · Codman & Shurtleff, Inc. · Radiology device
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Dec 1995
Decision
448d
Days
Class 2
Risk

K944612 is an FDA 510(k) clearance for the ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K944612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date December 11, 1995
Days to Decision 448 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
341d slower than avg
Panel avg: 107d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 939
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K952862 · Fujifilm Medical System U.S.A., Inc. · Sep 1995