Cleared Traditional

K033604 - TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

K033604 is an FDA 510(k) clearance for TRINGA ULTRASOUND IMAGING SYSTEM, manufactured by Pie Medical. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K033604 · Pie Medical · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
28d
Days
Class 2
Risk

K033604 is an FDA 510(k) clearance for the TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Pie Medical (Indianpolis, US). The FDA issued a Cleared decision on December 15, 2003 after a review of 28 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 - K033604

510(k) Number K033604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2003
Decision Date December 15, 2003
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 828
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K033604.
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
K040719 · Aloka Co., Ltd. · Mar 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · Siemens Medical Solutions USA, Inc. · Mar 2004
PORTASCAN BLADDER SCANNER, MODEL PA00146
K033906 · Mediwatch Plc · Dec 2003
DGH 55 HANDHELD PACHYMETER (PACHMATE)
K033385 · Dgh Technology, Inc. · Nov 2003
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · Accutome, Inc. · Oct 2003
ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
K032875 · Aloka Co. Ltd USA · Sep 2003
K033604 · TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
Download PDF FDA Summary Pie Medical