Cleared Traditional

K991738 - DIGITAL VIDEO RECORDING SYSTEM

K991738 is an FDA 510(k) clearance for DIGITAL VIDEO RECORDING SYSTEM, manufactured by Kay Elemetrics Corp.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K991738 · Kay Elemetrics Corp. · Radiology device
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Aug 1999
Decision
84d
Days
Class 2
Risk

K991738 is an FDA 510(k) clearance for the DIGITAL VIDEO RECORDING 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 Kay Elemetrics Corp. (Lincoln Park, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 84 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 Kay Elemetrics Corp. devices

FDA 510(k) Submission Details - K991738

510(k) Number K991738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1999
Decision Date August 13, 1999
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 1152
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K991738.
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
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AX WORKSTATION
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GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
K991629 · Ge Medical Systems, Inc. · Aug 1999
IMMERGE IMAGE CORRELATION
K991468 · Surgical Navigation Technologies, Inc. · Jul 1999
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
K991626 · Analogic Corp. · Jul 1999