Cleared Traditional

K883359 - DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A

K883359 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A, manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K883359 · Toshiba Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
168d
Days
Class 2
Risk

K883359 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on January 25, 1989 after a review of 168 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 Toshiba Medical Systems devices

FDA 510(k) Submission Details - K883359

510(k) Number K883359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1988
Decision Date January 25, 1989
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
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 426
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K883359.
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K891309 · Advanced Technology Laboratories, Inc. · May 1989
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
K890772 · Boston Scientific Corp · May 1989
RT6800 ECHOCARDIOGRAPHY SYSTEM
K885228 · General Electric Co. · Mar 1989
ACUSON I5100 ULTRASOUND TRANSDUCER
K884632 · Acuson Corp. · Jan 1989
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
K884395 · Hewlett-Packard Co. · Jan 1989
SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K875187 · Shimadzu Corp. · Dec 1988