Cleared Traditional

K931815 - 2000 X-RAY - TOMOGRAPHIC

K931815 is an FDA 510(k) clearance for 2000 X-RAY - TOMOGRAPHIC, manufactured by Imaging Sciences Intl., Inc.. The device is a Class 2 Radiology device with product code IZF cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K931815 · Imaging Sciences Intl., Inc. · Radiology device
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Aug 1993
Decision
137d
Days
Class 2
Risk

K931815 is an FDA 510(k) clearance for the 2000 X-RAY - TOMOGRAPHIC. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Imaging Sciences Intl., Inc. (Gwynedd, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 Imaging Sciences Intl., Inc. devices

FDA 510(k) Submission Details - K931815

510(k) Number K931815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date August 23, 1993
Days to Decision 137 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 107d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZF Device Classification - Class 2, Special Controls

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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 - IZF System, X-ray, Tomographic

All 33
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K931815.
BENNETT X-RAY TOMOGRAPHY SYSTEM
K945749 · Bennett X-Ray Corp. · Feb 1995
TOMO-LINK
K944967 · GE Medical Systems · Dec 1994
LINEAR TOMOGRAPHIC SYSTEM: PMT 6000
K942175 · Continental X-Ray Corp. · Aug 1994
PHILIPS INTEGRIS H/HM SYSTEM
K925302 · Philips Medical Systems, Inc. · Dec 1992
ORTHORALIX SD/ORTHORALIX SD CEPH
K890351 · Philips Medical Systems North America, Inc. · Jun 1989
RESUBMITTED SCANORA
K884650 · Orion Corp. · Mar 1989