Cleared Traditional

K080614 - DR VISION NEO, DR VISION DOU

K080614 is an FDA 510(k) clearance for DR VISION NEO, manufactured by Almana Medical Imaging. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K080614 · Almana Medical Imaging · Radiology device
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Jun 2008
Decision
107d
Days
Class 2
Risk

K080614 is an FDA 510(k) clearance for the DR VISION NEO, DR VISION DOU. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Almana Medical Imaging (Deer Field, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Almana Medical Imaging devices

FDA 510(k) Submission Details - K080614

510(k) Number K080614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2008
Decision Date June 20, 2008
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 218
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K080614.
DRAD30003/RADREX-I
K083503 · Toshiba America Medical Systems, In.C · Feb 2009
YSIO
K081722 · Siemens Medical Solutions USA, Inc. · Aug 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · Carestream Health, Inc. · Jul 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · Vieworks Co., Ltd. · Apr 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2008
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · Imaging Dynamics Company , Ltd. · Jun 2007