Cleared Traditional

ULTRA COMPACT VIDEO IMAGER (K930765) - FDA 510(k) Clearance

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

K930765 · International Imaging Electronics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
213d
Days
Class 2
Risk

K930765 is an FDA 510(k) clearance for the ULTRA COMPACT VIDEO IMAGER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by International Imaging Electronics (Bolingbrook, US). The FDA issued a Cleared decision on September 13, 1993 after a review of 213 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 International Imaging Electronics devices

Submission Details

510(k) Number K930765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1993
Decision Date September 13, 1993
Days to Decision 213 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K930765.
VOLUMETRIC RENDERING TECHNIQUE OPTION
K923524 · Siemens Medical Solutions USA, Inc. · May 1994
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K924985 · Siemens Medical Solutions USA, Inc. · Apr 1994
IMPAX 3000
K934832 · Heraeus Kulzer, Inc. · Dec 1993
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
K923077 · GE Medical Systems · Feb 1993
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
K921192 · GE Medical Systems · Oct 1992
WRIST RESTRAINT FOR GE9800 C.T. TABLES
K923108 · Cook, Inc. · Sep 1992