Cleared Traditional

K970680 - GLORY

K970680 is an FDA 510(k) clearance for GLORY, manufactured by Elscint, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K970680 · Elscint, Inc. · Radiology device
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Jun 1997
Decision
116d
Days
Class 2
Risk

K970680 is an FDA 510(k) clearance for the GLORY. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 Elscint, Inc. devices

FDA 510(k) Submission Details - K970680

510(k) Number K970680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date June 20, 1997
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 110
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K970680.
MAMMOTEST ADAPTER DRIVER
K973400 · Fischer Imaging Corp. · Nov 1997
PLANMED CYTOGUIDE
K973493 · Planmed OY · Nov 1997
INFLATABLE POSITIONING CUSHIONS
K973915 · Kci New Technologies, Inc. · Nov 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · Medical Marketing Intl., Inc. · Mar 1997
PLANNED SOPHIED CLASSIC
K962105 · Planmed OY · Feb 1997