Cleared Traditional

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory (K202742) - FDA 510(k) Clearance

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

K202742 · Viasonix , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
129d
Days
Class 2
Risk

K202742 is an FDA 510(k) clearance for the Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Viasonix , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on January 25, 2021 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Viasonix , Ltd. devices

Submission Details

510(k) Number K202742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2020
Decision Date January 25, 2021
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 107d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K202742.
SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
K201969 · CHISON Medical Technologies Co., Ltd. · Feb 2021
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
K201971 · CHISON Medical Technologies Co., Ltd. · Feb 2021
Lumify Diagnostic Ultrasound System
K203406 · Philips Ultrasound, Inc. · Feb 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
K202856 · Edan Instruments, Inc. · Jan 2021
LOGIQ P10, LOGIQ P9, LOGIQ P8
K203114 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2021
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
K202455 · Supersonic Imagine · Dec 2020