Cleared Traditional

K970782 - IMAGING JET SYSTEM (FDA 510(k) Clearance)

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

K970782 · General Robotic Devices, Inc. · Radiology device
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Nov 1997
Decision
254d
Days
Class 2
Risk

K970782 is an FDA 510(k) clearance for the IMAGING JET SYSTEM. Classified as System, X-ray, Fluoroscopic, Non-image-intensified (product code JAB), Class II - Special Controls.

Submitted by General Robotic Devices, Inc. (Ypsilanti, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 254 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1660 - 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 General Robotic Devices, Inc. devices

Submission Details

510(k) Number K970782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date November 13, 1997
Days to Decision 254 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 107d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAB System, X-ray, Fluoroscopic, Non-image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1660
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.