Cleared Traditional

K903326 - NIDEK US-2000

K903326 is an FDA 510(k) clearance for NIDEK US-2000, manufactured by Nidek, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K903326 · Nidek, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
119d
Days
Class 2
Risk

K903326 is an FDA 510(k) clearance for the NIDEK US-2000. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nidek, Inc. devices

FDA 510(k) Submission Details - K903326

510(k) Number K903326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date November 21, 1990
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
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 665
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K903326.
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
K903603 · Advanced Technology Laboratories, Inc. · Feb 1991
EUB-315
K905294 · Hitachi Medical Corp. of America · Feb 1991
EUB-565 DIAGNOSTIC ULTRASOUND DEVICE
K896100 · Hitachi Medical Corp. of America · Jan 1991
BIOPSY NEEDLE TRANSPONDER SYSTEM
K902214 · Advanced Technology Laboratories, Inc. · Nov 1990
NIDEK US-2500 W/BIOMETRY UNIT US-2520
K902411 · Nidek, Inc. · Oct 1990
OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM
K900881 · Codman & Shurtleff, Inc. · Sep 1990