Cleared Traditional

K043078 - NEMIO DIAGNOSTIC ULTRASOUND SYSTEM

K043078 is the FDA 510(k) clearance for NEMIO DIAGNOSTIC ULTRASOUND SYSTEM by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K043078 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
9d
Days
Class 2
Risk

K043078 is an FDA 510(k) clearance for the NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on November 17, 2004 after a review of 9 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K043078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date November 17, 2004
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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

Regulatory Technology Services, LLC
MARK JOB

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 408
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K043078.
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A
K051500 · Toshiba America Medical Systems, In.C · Jun 2005
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K043563 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
K043275 · Olympus Medical Systems Corporation · Dec 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · Siemens Medical Solutions USA, Inc. · Oct 2004
PHILIPS IU22 ULTRASOUND SYSTEM
K042540 · Philips Ultrasound, Inc. · Oct 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
K040719 · Aloka Co., Ltd. · Mar 2004