Cleared Traditional

INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA. (K900555) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900555 · Interson Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
85d
Days
Class 2
Risk

K900555 is an FDA 510(k) clearance for the INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Interson Corp. (Pleasanton, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Interson Corp. devices

Submission Details

510(k) Number K900555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1990
Decision Date May 02, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 100
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K900555.
UST-969-5 CONVEX TRANSDUCER
K905391 · Ge Medical Systems Information Technologies · Jan 1991
SONICATH(TM) 9F, 12 MHZ
K902245 · Boston Scientific Corp · Oct 1990
RADIUS AND SONOCHROME
K902070 · General Electric Co. · Aug 1990
SIEMENS ENDO-P-PROBE
K897098 · Siemens Medical Solutions USA, Inc. · Feb 1990
RADIUS CF
K894547 · General Electric Co. · Nov 1989
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · Siemens Medical Solutions USA, Inc. · Mar 1987