Cleared Traditional

K951999 - HOLOPSY SYSTEM

K951999 is an FDA 510(k) clearance for HOLOPSY SYSTEM, manufactured by Neovision Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K951999 · Neovision Corp. · Radiology device
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Jan 1996
Decision
252d
Days
Class 2
Risk

K951999 is an FDA 510(k) clearance for the HOLOPSY SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Neovision Corp. (Seattle, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 252 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Neovision Corp. devices

FDA 510(k) Submission Details - K951999

510(k) Number K951999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date January 05, 1996
Days to Decision 252 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 107d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 532
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