Cleared Traditional

K981535 - FOCUS PILOT CONTOURING WORKSTATION

K981535 is an FDA 510(k) clearance for FOCUS PILOT CONTOURING WORKSTATION, manufactured by Computerized Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K981535 · Computerized Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
338d
Days
Class 2
Risk

K981535 is an FDA 510(k) clearance for the FOCUS PILOT CONTOURING WORKSTATION. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Computerized Medical Systems, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 338 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 Computerized Medical Systems, Inc. devices

FDA 510(k) Submission Details - K981535

510(k) Number K981535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1998
Decision Date April 02, 1999
Days to Decision 338 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
231d slower than avg
Panel avg: 107d · This submission: 338d
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 331
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K981535.
PRIMUS
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