Cleared Traditional

K890638 - VOLUME COMPUTATION SOFTWARE PACKAGE

K890638 is an FDA 510(k) clearance for VOLUME COMPUTATION SOFTWARE PACKAGE, manufactured by Elscint, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K890638 · Elscint, Inc. · Cardiovascular device
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Aug 1989
Decision
180d
Days
Class 2
Risk

K890638 is an FDA 510(k) clearance for the VOLUME COMPUTATION SOFTWARE PACKAGE. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Elscint, Inc. devices

FDA 510(k) Submission Details - K890638

510(k) Number K890638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1989
Decision Date August 07, 1989
Days to Decision 180 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 54
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K890638.
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369 · Ge Medical Systems Information Technologies · Feb 1991
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264 · Millar Instruments, Inc. · Jan 1990
CARDIAC COMPUTATION SOFTWARE PACKAGE
K890636 · Elscint, Inc. · Aug 1989
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
K892944 · Interspec, Inc. · Jul 1989
RESUBMITTAL OF MI 1000C MICROIMAGER
K881979 · Ausonics Pty , Ltd. · Jun 1989
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · General Electric Co. · Nov 1988