Cleared Traditional

K953902 - GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM

K953902 is an FDA 510(k) clearance for GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM, manufactured by Medical Marketing Intl., Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 579-day FDA review.

K953902 · Medical Marketing Intl., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
579d
Days
Class 2
Risk

K953902 is an FDA 510(k) clearance for the GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Medical Marketing Intl., Inc. (Baton Rouge, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 579 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Medical Marketing Intl., Inc. devices

FDA 510(k) Submission Details - K953902

510(k) Number K953902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1995
Decision Date March 19, 1997
Days to Decision 579 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
472d slower than avg
Panel avg: 107d · This submission: 579d
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 104
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K953902.
INFLATABLE POSITIONING CUSHIONS
K973915 · Kci New Technologies, Inc. · Nov 1997
GLORY
K970680 · Elscint, Inc. · Jun 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
PLANNED SOPHIED CLASSIC
K962105 · Planmed OY · Feb 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · Bennett X-Ray Corp. · Jan 1997
THE ROBOGUIDE
K961849 · Shai Syg Motion and Innovations, Ltd. · Aug 1996