Cleared Traditional

K920041 - ADAC XL-PLAN-PC

K920041 is an FDA 510(k) clearance for ADAC XL-PLAN-PC, manufactured by Adac Laboratories. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K920041 · Adac Laboratories · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
84d
Days
Class 2
Risk

K920041 is an FDA 510(k) clearance for the ADAC XL-PLAN-PC. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K920041

510(k) Number K920041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date March 30, 1992
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 736
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K920041.
LINEAR ACCELERATOR COLLIMATOR
K911973 · Medical Equipment Development Co., Inc. · Oct 1992
SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63
K914698 · K.S., Inc. · Jun 1992
THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)
K920455 · S & S Inficon, Inc. · Mar 1992
SEQUENCER
K913612 · Impac Medical Systems, Inc. · Dec 1991
RECORD AND VERIFY MEVATRON ADAPTER
K913674 · Computerized Medical Systems, Inc. · Nov 1991
VARIAN C-SERIES CLINACS (CLINAC 2300C/D)
K913119 · Varian Assoc., Inc. · Nov 1991
K920041 · ADAC XL-PLAN-PC
Download PDF FDA Summary Adac Laboratories