Cleared Traditional

K913222 - OPTIMA

K913222 is an FDA 510(k) clearance for OPTIMA, manufactured by Olympic Controls Corp.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K913222 · Olympic Controls Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
154d
Days
Class 1
Risk

K913222 is an FDA 510(k) clearance for the OPTIMA. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Olympic Controls Corp. (Elgin, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 154 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Olympic Controls Corp. devices

FDA 510(k) Submission Details - K913222

510(k) Number K913222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1991
Decision Date December 20, 1991
Days to Decision 154 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
47d slower than avg
Panel avg: 107d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
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 - IZO Generator, High-voltage, X-ray, Diagnostic

All 100
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K913222.
X-RAY CONTROL AND HI-VOLTAGE GENERATOR
K921875 · Continental X-Ray Corp. · Oct 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951 · General Electric Co. · Jul 1992
X-RAY HIGH VOLTAGE GENERATOR ED 125L
K920730 · Shimadzu Medical Systems · Apr 1992
MICRO-X 50 HF
K914236 · Fischer Imaging Corp. · Nov 1991
MICRO-X 30 HF
K914266 · Fischer Imaging Corp. · Nov 1991
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
K911562 · Continental X-Ray Corp. · Oct 1991