Cleared Traditional

K914926 - SCANDIPLAN - VERSION 338

K914926 is an FDA 510(k) clearance for SCANDIPLAN - VERSION 338, manufactured by Scanditronix, Inc.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K914926 · Scanditronix, Inc. · Radiology device
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May 1992
Decision
206d
Days
Class 2
Risk

K914926 is an FDA 510(k) clearance for the SCANDIPLAN - VERSION 338. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Scanditronix, Inc. (Essex, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 206 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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 Scanditronix, Inc. devices

FDA 510(k) Submission Details - K914926

510(k) Number K914926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date May 28, 1992
Days to Decision 206 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
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 43
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K914926.
SIMVIEW(TM) 3000
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CMS RECORD AND VERIFY
K921108 · Computerized Medical Systems, Inc. · Nov 1992
ACQSIM SIMULATOR/LOCALIZER
K923851 · Philips Medical Systems (Cleveland), Inc. · Oct 1992
MODULEX RTP SYSTEM
K913017 · Computerized Medical Systems, Inc. · Oct 1991
XIMATRON/CT OPTION
K910647 · Fischer Imaging Corp. · Sep 1991
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991