Cleared Traditional

K844132 - MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER

K844132 is an FDA 510(k) clearance for MEDIVISION SERIES 5000 FLUOROSCOPIC DIG..., manufactured by Sigma Teleproducts, Inc.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K844132 · Sigma Teleproducts, Inc. · Radiology device
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Jan 1985
Decision
91d
Days
Class 1
Risk

K844132 is an FDA 510(k) clearance for the MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Sigma Teleproducts, Inc. (Hauppauge, US). The FDA issued a Cleared decision on January 22, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - 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 Sigma Teleproducts, Inc. devices

FDA 510(k) Submission Details - K844132

510(k) Number K844132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date January 22, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
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.