Cleared Traditional

K853115 - SONOLAYER S

K853115 is an FDA 510(k) clearance for SONOLAYER S, manufactured by Toshiba Medical Systems. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K853115 · Toshiba Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
231d
Days
Class 2
Risk

K853115 is an FDA 510(k) clearance for the SONOLAYER S, SSH-60A/SDS-60A. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 231 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 Toshiba Medical Systems devices

FDA 510(k) Submission Details - K853115

510(k) Number K853115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1985
Decision Date March 12, 1986
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K853115.
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859 · Biosound, Inc. · Feb 1987
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
SONOLINE SX ULTRASOUND SCANNER
K852739 · Siemens Medical Solutions USA, Inc. · Mar 1986
SONOLAYER S, SSH-65A
K854606 · Toshiba Medical Systems · Feb 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985