Cleared Traditional

K935615 - MEDICAL LINEAR ACCELERATOR

K935615 is an FDA 510(k) clearance for MEDICAL LINEAR ACCELERATOR, manufactured by Accelerator Systems Intl., Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 564-day FDA review.

K935615 · Accelerator Systems Intl., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
564d
Days
Class 2
Risk

K935615 is an FDA 510(k) clearance for the MEDICAL LINEAR ACCELERATOR. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Accelerator Systems Intl., Inc. (Milpitas, US). The FDA issued a Cleared decision on June 9, 1995 after a review of 564 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 Accelerator Systems Intl., Inc. devices

FDA 510(k) Submission Details - K935615

510(k) Number K935615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1993
Decision Date June 09, 1995
Days to Decision 564 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
457d slower than avg
Panel avg: 107d · This submission: 564d
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 593
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K935615.
MED-TEC RADIO THERAPY TREATMENT CHAIR
K951947 · Medtec, Inc. · Jul 1995
MED-TEC REDI-FOAM
K951808 · Medtec, Inc. · Jul 1995
MED-TEC KNEE CRUTCH
K951717 · Medtec, Inc. · Jun 1995
HIP FIXATION SYSTEM
K950866 · Medtec, Inc. · May 1995
VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0
K926449 · Varian Assoc., Inc. · May 1995
GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)
K934523 · Radionics, Inc. · Feb 1995