Cleared Traditional

K971368 - IDS4 IMAGE DISPLAY SYSTEM SERIES

K971368 is an FDA 510(k) clearance for IDS4 IMAGE DISPLAY SYSTEM SERIES, manufactured by O Tech, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K971368 · O Tech, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
73d
Days
Class 2
Risk

K971368 is an FDA 510(k) clearance for the IDS4 IMAGE DISPLAY SYSTEM SERIES. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by O Tech, Inc. (Plano, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all O Tech, Inc. devices

FDA 510(k) Submission Details - K971368

510(k) Number K971368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date June 26, 1997
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1306
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K971368.
KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER
K971973 · Eastman Kodak Company · Aug 1997
ECHOVACS
K971776 · Vmi Technologies · Jul 1997
INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
K965179 · Neo Imagery Technologies, Inc. · Jul 1997
STRATASYS FDM MEDMODELER SYSTEM
K971290 · Paladin Medical, Inc. · Jun 1997
NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO
K971714 · National Data Corp. · Jun 1997
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
K970964 · International Imaging Electronics · Jun 1997