Cleared Traditional

K970964 - MAESTRO DIGITAL IMAGE AND PATIENT RECOR...

K970964 is an FDA 510(k) clearance for MAESTRO DIGITAL IMAGE AND PATIENT RECOR..., manufactured by International Imaging Electronics. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K970964 · International Imaging Electronics · Radiology device
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Jun 1997
Decision
88d
Days
Class 2
Risk

K970964 is an FDA 510(k) clearance for the MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by International Imaging Electronics (Bolingbrook, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all International Imaging Electronics devices

FDA 510(k) Submission Details - K970964

510(k) Number K970964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date June 13, 1997
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1235
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