Cleared Traditional

K991133 - MLC FIT

K991133 is an FDA 510(k) clearance for MLC FIT, manufactured by Impac Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K991133 · Impac Medical Systems, Inc. · Radiology device
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Mar 2000
Decision
360d
Days
Class 2
Risk

K991133 is an FDA 510(k) clearance for the MLC FIT. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Impac Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 27, 2000 after a review of 360 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 Impac Medical Systems, Inc. devices

FDA 510(k) Submission Details - K991133

510(k) Number K991133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1999
Decision Date March 27, 2000
Days to Decision 360 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
253d slower than avg
Panel avg: 107d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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

All 548
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