Cleared Traditional

K122341 - PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM

K122341 is an FDA 510(k) clearance for PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Hitachi Aloka Medical, Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K122341 · Hitachi Aloka Medical, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
55d
Days
Class 2
Risk

K122341 is an FDA 510(k) clearance for the PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37. 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 Hitachi Aloka Medical, Ltd. (Wallingford, US). The FDA issued a Cleared decision on September 26, 2012 after a review of 55 days - a notably fast clearance cycle.

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: 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 Hitachi Aloka Medical, Ltd. devices

FDA 510(k) Submission Details - K122341

510(k) Number K122341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date September 26, 2012
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYN Device Classification - Class 2, Special Controls

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 923
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K122341.
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
K121564 · Olympus Medical Systems Corp. · Oct 2012
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K122114 · Ge Healthcare · Oct 2012
ACUSON
K122825 · Siemens Medical Solutions USA, Inc. · Sep 2012
VOLUSON E6/E8/E8EXPERT/E10
K122327 · Ge Healthcare · Sep 2012
E-CUBE 7
K121729 · Alpinion Medical Systems Co., Ltd. · Sep 2012
VIAMO SSA-640A V4.0
K122491 · Toshibamedical Systems Corporation · Sep 2012