Cleared Traditional

K911973 - LINEAR ACCELERATOR COLLIMATOR

K911973 is an FDA 510(k) clearance for LINEAR ACCELERATOR COLLIMATOR, manufactured by Medical Equipment Development Co., Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 531-day FDA review.

K911973 · Medical Equipment Development Co., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
531d
Days
Class 2
Risk

K911973 is an FDA 510(k) clearance for the LINEAR ACCELERATOR COLLIMATOR. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medical Equipment Development Co., Inc. (Cinnaminson, US). The FDA issued a Cleared decision on October 15, 1992 after a review of 531 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 Medical Equipment Development Co., Inc. devices

FDA 510(k) Submission Details - K911973

510(k) Number K911973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1991
Decision Date October 15, 1992
Days to Decision 531 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
424d slower than avg
Panel avg: 107d · This submission: 531d
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 564
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K911973.
REFIX(TM) SYSTEM
K930279 · Nomos Corp. · Jul 1993
PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM
K924495 · Philips Medical Systems, Inc. · Jun 1993
LCM-2-LINAC COUCH-MOUNT SYSTEM
K924632 · Radionics, Inc. · Apr 1993
ADAC XL-PLAN-PC
K920041 · Adac Laboratories · Mar 1992
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