Cleared Special

K143476 - Digi-One

K143476 is an FDA 510(k) clearance for Digi-One, manufactured by Rimed , Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 200-day FDA review.

K143476 · Rimed , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
200d
Days
Class 2
Risk

K143476 is an FDA 510(k) clearance for the Digi-One. 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 Rimed , Ltd. (Raanana, IL). The FDA issued a Cleared decision on June 23, 2015 after a review of 200 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K143476

510(k) Number K143476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2014
Decision Date June 23, 2015
Days to Decision 200 days
Submission Type Special
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
93d slower than avg
Panel avg: 107d · This submission: 200d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

A. Stein - Regulatory Affairs Consulting , Ltd.
AHAVA STEIN

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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1165
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K143476.
iuStar300 Medical Ultrasound Diagnostic System
K141720 · United Imaging Systems (Beijing) Co., Ltd. · Jul 2015
E-CUBE 15 Diagnostic Ultrasound System
K150773 · Alpinion Medical Systems Co., Ltd. · Jul 2015
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
K151451 · Toshibamedical Systems Corporation · Jul 2015
iNSIGHT Color Doppler Ultrasound System
K150002 · Saset (Chengdu), Inc. · Jun 2015
LOGIQ e
K151028 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2015
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015