Cleared Traditional

K972016 - AUTIMO 2.5-D AND AUTIMO 3-D

K972016 is an FDA 510(k) clearance for AUTIMO 2.5-D AND AUTIMO 3-D, manufactured by C.L. Mcintosh & Assoc., Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K972016 · C.L. Mcintosh & Assoc., Inc. · Radiology device
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Dec 1997
Decision
188d
Days
Class 2
Risk

K972016 is an FDA 510(k) clearance for the AUTIMO 2.5-D AND AUTIMO 3-D. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by C.L. Mcintosh & Assoc., Inc. (Rockville, US). The FDA issued a Cleared decision on December 4, 1997 after a review of 188 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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. Standard predicate reliance. 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 C.L. Mcintosh & Assoc., Inc. devices

FDA 510(k) Submission Details - K972016

510(k) Number K972016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date December 04, 1997
Days to Decision 188 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
81d slower than avg
Panel avg: 107d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 18
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K972016.
ENHANCED COMPENSATING FILTER
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AUTIMO
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K970303 · General Electric Co. · Apr 1997
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K961902 · Siemens Medical Solutions USA, Inc. · Aug 1996