Daylight Cassette Holders

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

Full name

Various Models of Daylight Cassette Holders

510(k) Number

K910111 ↗

FDA Product Code

IZH

Device Class

Class II

Regulation

21 CFR Part 892.1710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Magnaview M.R.I. Versions 110FH & 110FM W/Cardiac

  Class II

  FDA 510(k) K896309 Active Cleared 12 Jan 1990

• Instrumentarium MEGA4 Ht

  Class II

  FDA 510(k) K924921 Active Cleared 17 May 1993

• Delta 32 and Delta 32 Tact

  Class II

  FDA 510(k) K002472 Active Cleared 29 Nov 2000

• Mega 4 Magnetic Resonance Imaging System

  Class II

  FDA 510(k) K902044 Active Cleared 23 Aug 1990

• Instrumentarium MEGA4

  Class II

  FDA 510(k) K915552 Active Cleared 27 Feb 1992

• Magnaview Mobile MRI Version 110 Fhm

  Class II

  FDA 510(k) K891543 Active Cleared 23 Jun 1989

See all devices from Instrumentarium Imaging, Inc. →

• What are Daylight Cassette Holders used for in mammography?

  Daylight Cassette Holders are designed to support and position mammographic film cassettes during X-ray imaging. Their primary function is to ensure proper alignment and stability of the cassette, which helps achieve consistent and high-quality mammographic images. This stability reduces the risk of misalignment-related artifacts and improves diagnostic accuracy.

• Are these cassette holders reusable or single-use?

  These Daylight Cassette Holders are reusable devices. After use, they must be cleaned and maintained according to facility protocols to prevent contamination and ensure optimal performance. Regular maintenance is essential to uphold their structural integrity and imaging consistency.

• Do these cassette holders require sterilization?

  No specific sterility requirements are noted for these cassette holders. However, adherence to standard radiographic room hygiene practices is recommended to minimize contamination risks. This includes routine cleaning and disinfection as part of facility protocols to maintain a sterile environment in radiology settings.

• What models or variations of Daylight Cassette Holders are available?

  Multiple models of Daylight Cassette Holders are available, each with unique specifications and design features. These models are categorized under the product code IZH and are intended for use within mammography systems. The exact variations can be identified by their registration numbers, such as 3001722928, 3009470597, and others listed in the regulatory records.

• How should these cassette holders be stored?

  Daylight Cassette Holders should be stored in a clean, dry environment to prevent damage or contamination. They should be kept away from direct sunlight, extreme temperatures, and sources of moisture. Proper storage ensures their longevity and maintains their functionality for consistent use in mammographic imaging procedures.