Cleared Traditional

K833531 - CT SCANNING ACCESSORIES

K833531 is an FDA 510(k) clearance for CT SCANNING ACCESSORIES, manufactured by Lds Hospital. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K833531 · Lds Hospital · Radiology device
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Dec 1983
Decision
64d
Days
Class 2
Risk

K833531 is an FDA 510(k) clearance for the CT SCANNING ACCESSORIES. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Lds Hospital (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Lds Hospital devices

FDA 510(k) Submission Details - K833531

510(k) Number K833531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date December 08, 1983
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 195
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K833531.
DIGITAL RADIOGRAPHY SYS-DPS7100
K834287 · Adac Laboratories · Jan 1984
BI-PLANE DIGITAL FLUOROGRAPHY DFX7000
K834286 · Adac Laboratories · Jan 1984
IMAGE INTENSIFIER TUBE W/HOUSING &
K833641 · Varian Assoc., Inc. · Dec 1983
REGISTREX 1000 DIGITAL RADIOGRAPHY SYS
K833230 · Advanced Technology Laboratories, Inc. · Nov 1983
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530 · General Electric Co. · Nov 1983
HYPERLUX 30 IMAGE SYSTEM
K827489 · Cgr Medical Corp. · Nov 1982