Cleared Traditional

THE ROBOLITE (K964460) - FDA 510(k) Clearance

Class I Radiology device.

K964460 · Shai Syg Motion and Innovations, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
78d
Days
Class 1
Risk

K964460 is an FDA 510(k) clearance for the THE ROBOLITE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Shai Syg Motion and Innovations, Ltd. (Efrat, IL). The FDA issued a Cleared decision on January 24, 1997 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.2100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shai Syg Motion and Innovations, Ltd. devices

Submission Details

510(k) Number K964460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1996
Decision Date January 24, 1997
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQP Calculator/data Processing Module, For Clinical Use

All 30
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K964460.
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
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K885292 · Roche Diagnostic Systems, Inc. · Mar 1989
GLUCOFACTS DATA MANAGEMENT SYSTEM
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GLUCOFACTS DATA PRINTER
K861779 · Miles Laboratories, Inc. · Aug 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · Miles Laboratories, Inc. · Jul 1986
DIRECT READOUT MODULE ACCESSORY
K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986