Cleared Traditional

K940539 - STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM

K940539 is an FDA 510(k) clearance for STAND IMAGING DOSE CALIBRATOR SHIELDED ..., manufactured by Standard Imaging, Inc.. The device is a Class 1 Radiology device with product code KPY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K940539 · Standard Imaging, Inc. · Radiology device
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Mar 1994
Decision
37d
Days
Class 1
Risk

K940539 is an FDA 510(k) clearance for the STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM. Classified as Shield, Protective, Personnel (product code KPY), Class I - General Controls.

Submitted by Standard Imaging, Inc. (Middleton, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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.

FDA 510(k) Submission Details - K940539

510(k) Number K940539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date March 16, 1994
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

KPY Device Classification - Class 1, General Controls

Product Code KPY Shield, Protective, Personnel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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 - KPY Shield, Protective, Personnel

All 16
Devices cleared under the same product code (KPY) and FDA review panel - the closest regulatory comparables to K940539.
AUKULYTE
K953610 · Aukland Medical Plastics, Inc. · Sep 1995
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
K951004 · Kenex , Ltd. · Apr 1995
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
K951003 · Kenex , Ltd. · Apr 1995
MAVIG ANGIO SHIELD MODELS 6290 & 6272
K934206 · F. Walter Hanel GmbH · Oct 1993
DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS
K912326 · Davis Lead Aprons, Inc. · Mar 1992
DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.
K912327 · Davis Lead Aprons, Inc. · Mar 1992
K940539 · STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
Download PDF Standard Imaging, Inc.