Cleared Traditional

K833560 - RTP-5100-5200-5300 & 5400

K833560 is an FDA 510(k) clearance for RTP-5100-5200-5300 & 5400, manufactured by Adac Laboratories. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K833560 · Adac Laboratories · Radiology device
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Dec 1983
Decision
51d
Days
Class 2
Risk

K833560 is an FDA 510(k) clearance for the RTP-5100-5200-5300 & 5400. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Adac Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Adac Laboratories devices

FDA 510(k) Submission Details - K833560

510(k) Number K833560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date December 08, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 37
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K833560.
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377 · Siemens Medical Solutions USA, Inc. · Sep 1990
CMS RECORD AND VERIFY SYSTEM
K882484 · Computerized Medical Systems, Inc. · Dec 1988
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
K844424 · Varian Assoc., Inc. · Feb 1985
RTP-5000
K813439 · Adac Laboratories · Jan 1982