Cleared Traditional

K884650 - RESUBMITTED SCANORA

K884650 is an FDA 510(k) clearance for RESUBMITTED SCANORA, manufactured by Orion Corp.. The device is a Class 2 Radiology device with product code IZF cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K884650 · Orion Corp. · Radiology device
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Mar 1989
Decision
129d
Days
Class 2
Risk

K884650 is an FDA 510(k) clearance for the RESUBMITTED SCANORA. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on March 16, 1989 after a review of 129 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 Orion Corp. devices

FDA 510(k) Submission Details - K884650

510(k) Number K884650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date March 16, 1989
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 107d · This submission: 129d
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 30
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K884650.
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
ORALIX PANORAMIC D.C.
K852768 · Philips Medical Systems, Inc. · Sep 1985
DIGITILT LS-30 REMOTE CONTROL
K834288 · Elscint, Inc. · Dec 1983
SOMATOM 2N
K811302 · Siemens Corp. · Jun 1981