Cleared Traditional

K991842 - SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING

K991842 is an FDA 510(k) clearance for SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IM..., manufactured by Ge Vingmed Ultrasound. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K991842 · Ge Vingmed Ultrasound · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
14d
Days
Class 2
Risk

K991842 is an FDA 510(k) clearance for the SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ge Vingmed Ultrasound (Horten, NO). The FDA issued a Cleared decision on June 11, 1999 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Vingmed Ultrasound devices

FDA 510(k) Submission Details - K991842

510(k) Number K991842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date June 11, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Consultant

Underwriters Laboratories, Inc.
CHANTEL CARSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 567
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K991842.
AMIB7
K990198 · Alliance Medical, Inc. · Jun 1999
LONGPORT MODEL LDS -1
K990238 · Longport, Inc. · Jun 1999
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K991671 · Advanced Technology Laboratories, Inc. · Jun 1999
GE LOGIQ 500
K991611 · General Electric Co. · Jun 1999
SSA-370A/POWERVISION 6000
K991710 · Toshiba America Medical Systems, In.C · Jun 1999
LIFE IMAGING SYSTEMS, MODEL L3DI
K990560 · Life Imaging Systems, Inc. · May 1999