Cleared Traditional

K992575 - CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000

K992575 is an FDA 510(k) clearance for CARDIOVASCULAR WORKSTATION, manufactured by Infimed, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992575 · Infimed, Inc. · Radiology device
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Oct 1999
Decision
66d
Days
Class 2
Risk

K992575 is an FDA 510(k) clearance for the CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000. 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 Infimed, Inc. (Liverpool, US). The FDA issued a Cleared decision on October 7, 1999 after a review of 66 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 Infimed, Inc. devices

FDA 510(k) Submission Details - K992575

510(k) Number K992575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date October 07, 1999
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
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 1290
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K992575.
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
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ECHOCARDIOGRAPHY SYSTEM SERIES 95000
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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