Cleared Traditional

K974698 - SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS (FDA 510(k) Clearance)

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

K974698 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
204d
Days
Class 2
Risk

K974698 is an FDA 510(k) clearance for the SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on July 8, 1998 after a review of 204 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K974698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1997
Decision Date July 08, 1998
Days to Decision 204 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 397
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K974698.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · Boston Scientific Cardiac Diagnostic Technologies, Inc. · Jan 2026
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356 · Infobionic, Inc. · Jul 2025
Zio AT® device (A100A1001)
K240177 · iRhythm Technologies, Inc. · Oct 2024
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · Infobionic, Inc. · Oct 2023