Cleared Traditional

K930506 - THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM

K930506 is an FDA 510(k) clearance for THERPAC RADIOTHERAPY TREATMENT PLANNING..., manufactured by Pinecliff Assoc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 574-day FDA review.

K930506 · Pinecliff Assoc. · Radiology device
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Aug 1994
Decision
574d
Days
Class 2
Risk

K930506 is an FDA 510(k) clearance for the THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Pinecliff Assoc. (Wilmington, US). The FDA issued a Cleared decision on August 29, 1994 after a review of 574 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Pinecliff Assoc. devices

FDA 510(k) Submission Details - K930506

510(k) Number K930506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date August 29, 1994
Days to Decision 574 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
467d slower than avg
Panel avg: 107d · This submission: 574d
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 595
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