Cleared Traditional

CONCEPT ONE (K933777) - FDA 510(k) Clearance

Class I Radiology device.

K933777 · Innerscan, Inc. · Radiology device
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Dec 1993
Decision
132d
Days
Class 1
Risk

K933777 is an FDA 510(k) clearance for the CONCEPT ONE. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Innerscan, Inc. (Wheeling, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 132 days - within the typical 510(k) review window.

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 Innerscan, Inc. devices

Submission Details

510(k) Number K933777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date December 13, 1993
Days to Decision 132 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
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 28
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K933777.
KXO-80G
K945668 · Toshiba America Medical Systems, In.C · Dec 1994
VASCULAR MP X-RAY GENERATOR
K943652 · GE Medical Systems · Aug 1994
SCPU X-RAY GENERATOR
K940227 · General Electric Co. · Apr 1994
POYDOROS LX
K931930 · Siemens Medical Solutions USA, Inc. · Sep 1993
POLYDOROS IS
K933240 · Siemens Medical Solutions USA, Inc. · Sep 1993
LCR GENERATOR
K931998 · Philips Medical Systems (Cleveland), Inc. · Jul 1993