Cleared Traditional

K981553 - AUTOMATED MEDICAL REPORT WRITER

K981553 is an FDA 510(k) clearance for AUTOMATED MEDICAL REPORT WRITER, manufactured by Woodson and Associates, LLC. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K981553 · Woodson and Associates, LLC · Radiology device
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Sep 1998
Decision
151d
Days
Class 2
Risk

K981553 is an FDA 510(k) clearance for the AUTOMATED MEDICAL REPORT WRITER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Woodson and Associates, LLC (Decatur, US). The FDA issued a Cleared decision on September 29, 1998 after a review of 151 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Woodson and Associates, LLC devices

FDA 510(k) Submission Details - K981553

510(k) Number K981553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date September 29, 1998
Days to Decision 151 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 346
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K981553.
FORTE
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