Cleared Special

K082064 - RADVISION ET DIAGNOSTIC X-RAY SYSTEM

K082064 is an FDA 510(k) clearance for RADVISION ET DIAGNOSTIC X-RAY SYSTEM, manufactured by Almana Medical Imaging. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 32-day FDA review.

K082064 · Almana Medical Imaging · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
32d
Days
Class 2
Risk

K082064 is an FDA 510(k) clearance for the RADVISION ET DIAGNOSTIC X-RAY SYSTEM. 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 August 22, 2008 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082064

510(k) Number K082064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2008
Decision Date August 22, 2008
Days to Decision 32 days
Submission Type Special
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
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 328
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K082064.
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K082261 · Dxrad Solutions , Ltd. · Nov 2008
DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000
K082798 · Medicatech USA · Oct 2008
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
DR VISION NEO, DR VISION DOU
K080614 · Almana Medical Imaging · Jun 2008
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
K080582 · Medicatech USA · May 2008
K082064 · RADVISION ET DIAGNOSTIC X-RAY SYSTEM
Download PDF FDA Summary Almana Medical Imaging