Kodak RVG 6500 System and Kodak RVG 6500 IPS System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K093478 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• CS 8100SC, CS8100SC Access

  Class II

  FDA 510(k) K151087 Active Cleared 21 Aug 2015

• CS Imaging

  Class II

  FDA 510(k) K173622 Active Cleared 16 Jan 2018

• Cs 9600 Open recall

  Class II

  FDA 510(k) K200183 Active Cleared 13 Mar 2020

• CS 3D Imaging

  Class II

  FDA 510(k) K151837 Active Cleared 19 Aug 2015

• Cs 8100 3D

  Class II

  FDA 510(k) K133406 Active Cleared 14 Mar 2014

• Cs 8100 Cs 8100 Access

  Class II

  FDA 510(k) K120975 Active Cleared 22 Jun 2012

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• What is the Kodak RVG 6500 System used for?

  The Kodak RVG 6500 System is designed for dental imaging, specifically to produce high-resolution radiographic images of the dento-maxillofacial region. This includes detailed visualization of teeth, jawbone, and surrounding structures, enabling precise diagnostic evaluations for dental professionals in clinical settings.

• How is the Kodak RVG 6500 System supplied and what is its sterility status?

  The Kodak RVG 6500 System is supplied as a reusable medical device. The provided data does not specify a sterility designation, meaning it is not pre-sterilized for single-use. Users must follow manufacturer guidelines for cleaning, disinfection, and maintenance to ensure safe reuse in dental clinics.

• Is the Kodak RVG 6500 System suitable for MRI environments?

  The available data does not include any information regarding MRI safety for the Kodak RVG 6500 System. Clinicians should consult the manufacturer’s instructions or safety documentation to determine compatibility with MRI environments before use.

• What regulatory pathway does the Kodak RVG 6500 System follow?

  The Kodak RVG 6500 System has received FDA 510(k) clearance under the Traditional pathway. It is classified as a Class II device under regulation number 872.1800, indicating it has been determined to be substantially equivalent to a legally marketed predicate device for dental X-ray imaging.

• Are there different models or configurations available for the Kodak RVG 6500 System?

  Yes, there are two primary configurations: the Kodak RVG 6500 System and the Kodak RVG 6500 IPS System. Both operate as wireless digital intraoral X-ray devices with extraoral X-ray sources and digital capture capabilities. The IPS variant may include additional features or improvements, but the core function remains focused on high-resolution dental imaging.