Cleared Traditional

K974522 - 3D I-SCAN

K974522 is an FDA 510(k) clearance for 3D I-SCAN, manufactured by Ophthalmic Technologies, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K974522 · Ophthalmic Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
85d
Days
Class 2
Risk

K974522 is an FDA 510(k) clearance for the 3D I-SCAN. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ophthalmic Technologies, Inc. (Hasbrouck, US). The FDA issued a Cleared decision on February 25, 1998 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Ophthalmic Technologies, Inc. devices

FDA 510(k) Submission Details - K974522

510(k) Number K974522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1997
Decision Date February 25, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 527
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K974522.
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
K980851 · Boston Scientific Corp · Apr 1998
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM
K980860 · Atlantis Diagnostics Intl., Inc. · Apr 1998
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K973802 · Shimadzu Medical Systems · Mar 1998
ULTRAGUIDE 1000
K974432 · Ultraguide , Ltd. · Feb 1998
HARMONIC IMAGING WITH CONTRAST
K973767 · Acuson Corp. · Dec 1997
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
K970901 · GE Medical Systems · Dec 1997