Cleared Traditional

K101337 - A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

K101337 is an FDA 510(k) clearance for A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM, manufactured by Sonoscape Company Limited. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K101337 · Sonoscape Company Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
141d
Days
Class 2
Risk

K101337 is an FDA 510(k) clearance for the A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Sonoscape Company Limited (Shanghai, CN). The FDA issued a Cleared decision on September 30, 2010 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Sonoscape Company Limited devices

FDA 510(k) Submission Details - K101337

510(k) Number K101337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date September 30, 2010
Days to Decision 141 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 452
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K101337.
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K111706 · Volcano Corporation · Jul 2011
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K111435 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2011
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K102991 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · Hitachi Medical Systems America, Inc. · Jun 2010
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · Aloka Co., Ltd. · Nov 2009
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
K082229 · Volcano Corporation · Oct 2008