Fluorovision HR 2000 High Resolution Image Enhance

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K895320 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Real-Time Video Contrast Enhancer

  Class II

  FDA 510(k) K962260 Active Cleared 9 Sep 1996

• Digiviewer

  Class II

  FDA 510(k) K873646 Active Cleared 8 Oct 1987

• Fluorovision Contrast Enhancer

  Class II

  FDA 510(k) K864584 Active Cleared 29 Dec 1986

• What type of medical environment is the Fluorovision HR 2000 designed for, and how does it improve diagnostic imaging?

  The Fluorovision HR 2000 is specifically designed for radiology settings where fluoroscopic imaging is performed. It enhances image resolution, which significantly improves diagnostic clarity during radiographic procedures. This means clinicians can better visualize internal structures, reducing the need for repeated imaging and improving accuracy in procedures like angiography or orthopedic evaluations.

• Is the Fluorovision HR 2000 a single-use or reusable device, and what does that mean for maintenance?

  The Fluorovision HR 2000 is a reusable medical instrument, meaning it is intended to be cleaned, disinfected, and reused multiple times. This design reduces waste and cost over time but requires adherence to strict infection control protocols and regular maintenance to ensure consistent performance and safety. The manufacturer’s instructions should be followed for proper care and upkeep.

• How is the Fluorovision HR 2000 regulated, and what does its FDA 510(k) clearance indicate?

  The Fluorovision HR 2000 holds an FDA 510(k) clearance under the reference number K895320, filed in 1989. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed device already on the market at the time of submission. It does not imply ongoing approval but confirms that the device met regulatory standards for safety and effectiveness as of its clearance date.

• Are there any special storage requirements for the Fluorovision HR 2000, and does it have any MRI safety considerations?

  The available data does not specify any special storage requirements for the Fluorovision HR 2000 beyond standard environmental controls for medical imaging equipment. Additionally, there are no explicit MRI safety constraints mentioned, meaning it is not labeled as MRI-compatible or unsafe for use in MRI environments. However, it is always best to consult the manufacturer’s guidelines for proper handling and storage.