Cleared Traditional

K902007 - I3SYSTEM-ABD

K902007 is an FDA 510(k) clearance for I3SYSTEM-ABD, manufactured by Innovative Imaging, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K902007 · Innovative Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
77d
Days
Class 2
Risk

K902007 is an FDA 510(k) clearance for the I3SYSTEM-ABD. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Innovative Imaging, Inc. (Sacramento, US). The FDA issued a Cleared decision on July 20, 1990 after a review of 77 days - a notably fast clearance 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: 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 Innovative Imaging, Inc. devices

FDA 510(k) Submission Details - K902007

510(k) Number K902007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1990
Decision Date July 20, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
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 584
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K902007.
EUB-515 DIAGNOSTIC ULTRASOUND DEVICE
K897042 · Hitachi Medical Corp. of America · Sep 1990
ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K900805 · Ge Medical Systems Information Technologies · Aug 1990
SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT
K896999 · Shimadzu Corp. · Aug 1990
SIEMENS SONOLINE AC
K896480 · Siemens Medical Solutions USA, Inc. · Jul 1990
AUSONICS 5000
K896714 · Ausonics Pty , Ltd. · Jun 1990
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K896755 · Ge Medical Systems Information Technologies · May 1990