Cleared Traditional

K993750 - PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO

K993750 is an FDA 510(k) clearance for PROSOLV ECHOVIEWER, manufactured by Problem Solving Concepts, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K993750 · Problem Solving Concepts, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K993750

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
Combination Product No
PCCP Authorized No
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.

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 1458
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K993750.
ISSA PHAROS
K994054 · Vams Tec, D.O.O. · Feb 2000
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K000015 · Barco N.V. · Feb 2000
INTURIS SUITE
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SHARPVIEW IMAGE ENHANCEMENT SYSTEM
K993802 · Context Vision AB · Jan 2000
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
K993283 · Arnold & Richter Cine Technik · Dec 1999
INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
K993338 · Ibm Israel , Ltd. · Dec 1999