Cleared Traditional

K900881 - OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM

K900881 is the FDA 510(k) clearance for OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM by Codman & Shurtleff, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K900881 · Codman & Shurtleff, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
211d
Days
Class 2
Risk

K900881 is an FDA 510(k) clearance for the OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Attleboro, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 211 days - an extended review 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: 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K900881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1990
Decision Date September 25, 1990
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 338
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K900881.
NIDEK US-2000
K903326 · Nidek, Inc. · Nov 1990
BIOPSY NEEDLE TRANSPONDER SYSTEM
K902214 · Advanced Technology Laboratories, Inc. · Nov 1990
NIDEK US-2500 W/BIOMETRY UNIT US-2520
K902411 · Nidek, Inc. · Oct 1990
ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K900805 · Ge Medical Systems Information Technologies · Aug 1990
SIEMENS SONOLINE AC
K896480 · Siemens Medical Solutions USA, Inc. · Jul 1990
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K896755 · Ge Medical Systems Information Technologies · May 1990