Cleared Traditional

K827489 - HYPERLUX 30 IMAGE SYSTEM

K827489 is an FDA 510(k) clearance for HYPERLUX 30 IMAGE SYSTEM, manufactured by Cgr Medical Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway .

K827489 · Cgr Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K827489

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
Combination Product No
PCCP Authorized No
Regulatory Context
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 154
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K827489.
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
LATERAL ANGULATING FLUORO SUSPENSION
K820184 · General Electric Co. · Feb 1982
DIGITAL FLUROGRAPHIC IMAGING SYSTEM
K813217 · Diasonics, Inc. · Dec 1981
IBIS II
K812963 · Cgr Medical Corp. · Nov 1981