Cleared Traditional

K834281 - RAD II SIMULATOR

K834281 is an FDA 510(k) clearance for RAD II SIMULATOR, manufactured by Haynes Radiation Ltd., Inc.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K834281 · Haynes Radiation Ltd., Inc. · Radiology device
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Dec 1983
Decision
57d
Days
Class 2
Risk

K834281 is an FDA 510(k) clearance for the RAD II SIMULATOR. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Haynes Radiation Ltd., Inc. (Alameda, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Haynes Radiation Ltd., Inc. devices

FDA 510(k) Submission Details - K834281

510(k) Number K834281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1983
Decision Date December 29, 1983
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
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 K834281.
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
K853349 · Varian Assoc., Inc. · Oct 1985
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
K851813 · Victoreen, Inc. · Aug 1985
VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
K851653 · Varian Assoc., Inc. · May 1985
XIMATRON V
K810858 · Siemens Corp. · May 1981
SIDOS U.
K803124 · Siemens Corp. · Jan 1981
RADIATION ONCOLOGY SYSTEM
K782005 · Adac Laboratories · Dec 1978