Cleared Traditional

K922310 - VORTECH'S PERSONAL DISPLAY SYSTEM

K922310 is an FDA 510(k) clearance for VORTECH'S PERSONAL DISPLAY SYSTEM, manufactured by Vortech Data, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K922310 · Vortech Data, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
73d
Days
Class 2
Risk

K922310 is an FDA 510(k) clearance for the VORTECH'S PERSONAL DISPLAY SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Vortech Data, Inc. (Richardson, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Vortech Data, Inc. devices

FDA 510(k) Submission Details - K922310

510(k) Number K922310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1992
Decision Date July 30, 1992
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 2079
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K922310.
DU PONT LINX HD-25 LASR IMAGER
K923042 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1992
SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI
K920319 · Siemens Gammasonics, Inc. · Oct 1992
KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI
K923270 · Eastman Kodak Company · Sep 1992
PHILIPS EASYVISION
K920950 · Philips Medical Systems, Inc. · Apr 1992
SIENET DIAGNOSTIC REPORTING CONSOLE
K920309 · Siemens Gammasonics, Inc. · Mar 1992
MEDRAD PATHFINDER HR ROADMAPPING SYSTEM
K914366 · Medrad, Inc. · Feb 1992