Cleared Traditional

K060800 - SEEKER/SPARK ULTRASOUND SYSTEM

K060800 is an FDA 510(k) clearance for SEEKER/SPARK ULTRASOUND SYSTEM, manufactured by Ardent Sound, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K060800 · Ardent Sound, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
14d
Days
Class 2
Risk

K060800 is an FDA 510(k) clearance for the SEEKER/SPARK ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ardent Sound, Inc. (Mesa, US). The FDA issued a Cleared decision on April 7, 2006 after a review of 14 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.

FDA 510(k) Submission Details - K060800

510(k) Number K060800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2006
Decision Date April 07, 2006
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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

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 849
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K060800.
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K060949 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
IVIEW
K053306 · Ondemandsoft · Apr 2006
VUMAX
K060626 · Sonomed, Inc. · Apr 2006
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900
K053346 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2005
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY)
K053325 · Mediwatch, Ltd. · Dec 2005
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
K052348 · Volcano Corporation · Dec 2005
K060800 · SEEKER/SPARK ULTRASOUND SYSTEM
Download PDF FDA Summary Ardent Sound, Inc.