Cleared Traditional

PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO (K993750) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993750 · Problem Solving Concepts, Inc. · Radiology device
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Feb 2000
Decision
89d
Days
Class 2
Risk

K993750 is an FDA 510(k) clearance for the PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHO.... 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 Problem Solving Concepts, Inc. (Carmel, US). The FDA issued a Cleared decision on February 2, 2000 after a review of 89 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 Problem Solving Concepts, Inc. devices

Submission Details

510(k) Number K993750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1999
Decision Date February 02, 2000
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 768
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K993750.
SYNGO MULTIMODALITY WORKSTATION
K010938 · Siemens Medical Solutions USA, Inc. · Jun 2001
ODYSSEY LX, MODEL 211320
K003437 · Philips Medical Systems (Cleveland), Inc. · Feb 2001
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · Toshiba America Medical Systems, In.C · Oct 2000
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
K992886 · Toshiba America Medical Systems, In.C · Nov 1999
AX WORKSTATION
K992073 · Siemens Medical Solutions USA, Inc. · Sep 1999
ADVANTAGE WINDOWS (AW) FUSION
K983256 · GE Medical Systems · Dec 1998