Cleared Traditional

K852739 - SONOLINE SX ULTRASOUND SCANNER

K852739 is the FDA 510(k) clearance for SONOLINE SX ULTRASOUND SCANNER by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K852739 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Mar 1986
Decision
256d
Days
Class 2
Risk

K852739 is an FDA 510(k) clearance for the SONOLINE SX ULTRASOUND SCANNER. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 256 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 K852739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1985
Decision Date March 10, 1986
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 35
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K852739.
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657 · Advanced Technology Laboratories, Inc. · Feb 1987
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710 · Johnson & Johnson Professionals, Inc. · Jul 1986
SONOLAYER S, SSH-60A/SDS-60A
K853115 · Toshiba Medical Systems · Mar 1986
SONOLAYER S, SSH-65A
K854606 · Toshiba Medical Systems · Feb 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985