Cleared Traditional

HYPERLUX 30 IMAGE SYSTEM (K827489) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K827489 · Cgr Medical Corp. · Radiology device
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Nov 1982
Decision
-
Days
Class 2
Risk

K827489 is an FDA 510(k) clearance for the HYPERLUX 30 IMAGE SYSTEM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Cgr Medical Corp. (Columbia, US). The FDA issued a Cleared decision on November 4, 1982.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cgr Medical Corp. devices

Submission Details

510(k) Number K827489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1982
Decision Date November 04, 1982
Days to Decision -
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K827489.
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530 · General Electric Co. · Nov 1983
LATERAL ANGULATING FLUORO SUSPENSION
K820184 · General Electric Co. · Feb 1982
FLUORICON L300 IMAGE INTENSIFIER
K812775 · General Electric Co. · Nov 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561 · General Electric Co. · Oct 1981