Cleared Traditional

K851901 - 750 SD ULTRASOUND SCANNER(MODIFICATION)

K851901 is an FDA 510(k) clearance for 750 SD ULTRASOUND SCANNER(MODIFICATION), manufactured by Ultrasonix, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K851901 · Ultrasonix, Inc. · Cardiovascular device
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Oct 1985
Decision
176d
Days
Class 2
Risk

K851901 is an FDA 510(k) clearance for the 750 SD ULTRASOUND SCANNER(MODIFICATION). Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Ultrasonix, Inc. (N. Yonkers, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 176 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 Ultrasonix, Inc. devices

FDA 510(k) Submission Details - K851901

510(k) Number K851901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1985
Decision Date October 23, 1985
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
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 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K851901.
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
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · Del Mar Avionics · Jun 1985
CARDIOSCAN - TM BEING APPLIED FOR
K841263 · Interspec, Inc. · Oct 1984