Cleared Traditional

K934949 - DIGORA

K934949 is an FDA 510(k) clearance for DIGORA, manufactured by Orion Corporation Soredex. The device is a Class 2 Radiology device with product code IXK cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K934949 · Orion Corporation Soredex · Radiology device
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Feb 1994
Decision
115d
Days
Class 2
Risk

K934949 is an FDA 510(k) clearance for the DIGORA. Classified as System, Imaging, X-ray, Electrostatic (product code IXK), Class II - Special Controls.

Submitted by Orion Corporation Soredex (Helsinki, FI). The FDA issued a Cleared decision on February 10, 1994 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1630 - 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 Corporation Soredex devices

FDA 510(k) Submission Details - K934949

510(k) Number K934949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date February 10, 1994
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXK Device Classification - Class 2, Special Controls

Product Code IXK System, Imaging, X-ray, Electrostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1630
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 - IXK System, Imaging, X-ray, Electrostatic

All 8
Devices cleared under the same product code (IXK) and FDA review panel - the closest regulatory comparables to K934949.
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689 · Canon USA, Inc. · Jan 2002
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · Agfa Corp. · Feb 2000
FUJI FCR IMAGE PROCESSING UNIT IP-U515
K942561 · Fujifilm Medical System U.S.A., Inc. · Dec 1994
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
K931002 · Fujifilm Medical System U.S.A., Inc. · Jun 1993
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE
K923990 · Fujifilm Medical System U.S.A., Inc. · Dec 1992
DIGISCAN 2
K924459 · Siemens Medical Solutions USA, Inc. · Dec 1992