Cleared Traditional

K894412 - RADIOSCOPE OR MAMMOSCOPE

K894412 is an FDA 510(k) clearance for RADIOSCOPE OR MAMMOSCOPE, manufactured by Vision Ten, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K894412 · Vision Ten, Inc. · Radiology device
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Dec 1989
Decision
158d
Days
Class 2
Risk

K894412 is an FDA 510(k) clearance for the RADIOSCOPE OR MAMMOSCOPE. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Vision Ten, Inc. (Washington, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 158 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 Vision Ten, Inc. devices

FDA 510(k) Submission Details - K894412

510(k) Number K894412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date December 22, 1989
Days to Decision 158 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 107d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 36
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K894412.
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