Cleared Traditional

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED (K921740) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921740 · Medical Instrumentation & Diagnostics Corp.(Midco) · Radiology device
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Apr 1993
Decision
359d
Days
Class 2
Risk

K921740 is an FDA 510(k) clearance for the COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medical Instrumentation & Diagnostics Corp.(Midco) (Albuquerque, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Instrumentation & Diagnostics Corp.(Midco) devices

Submission Details

510(k) Number K921740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date April 07, 1993
Days to Decision 359 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 107d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

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