CT Blankets (Bolus Material)

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

510(k) Number

K780737 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Scanner-Emi 7020 and 7020R

  Class II

  FDA 510(k) K781936 Active Cleared 4 Dec 1978

• Emi Ctr 100

  Class II

  FDA 510(k) K771811 Active Cleared 19 Oct 1977

• Ctr 100l

  Class II

  FDA 510(k) K771978 Active Cleared 23 Nov 1977

• Emi Simulator Remote Control Console

  Class II

  FDA 510(k) K781519 Active Cleared 14 Sep 1978

• Emisonic 4290

  Class II

  FDA 510(k) K791429 Active Cleared 21 Sep 1979

• Emisonic 4500 Tm

  Class II

  FDA 510(k) K771930 Active Cleared 27 Oct 1977

See all devices from Emi Medical, Inc. →

• What is the primary purpose of CT Blankets (Bolus Material) in CT imaging, and how do they improve scan quality?

  CT Blankets (Bolus Material) are designed to enhance contrast in CT scans by mimicking the density of soft tissue. They are placed over areas where natural tissue contrast is insufficient, helping to better visualize anatomical structures during imaging. This improves the clarity and definition of the scan, particularly in regions like the neck, shoulders, or limbs where differentiation between tissues can be challenging.

• Are CT Blankets (Bolus Material) reusable, and if not, what are the handling and disposal guidelines?

  No, CT Blankets are supplied as single-use items, meaning they are intended for one-time use only. Since they are not sterile, they must be handled according to standard radiology protocols to ensure patient safety and prevent contamination. After use, they should be disposed of following your facility’s standard medical waste guidelines.

• Are there any special storage requirements for CT Blankets, and how should they be kept before use?

  The device data does not specify special storage conditions beyond standard radiology protocols. However, since these blankets are single-use and non-sterile, they should be stored in a clean, dry environment, protected from moisture and physical damage. Always check the packaging for any manufacturer-specific storage instructions before use.

• How is the regulatory status of CT Blankets (Bolus Material) determined, and what does this mean for clinicians?

  The CT Blankets received FDA 510(k) clearance under product code JAK, meaning they were determined to be substantially equivalent to a legally marketed device already on the market. This classification ensures they meet regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as an indication that the device has undergone review by the FDA’s Radiology Advisory Committee and is suitable for use in radiology settings as described.

• Can CT Blankets (Bolus Material) be used in MRI settings, or are there any safety considerations for magnetic resonance imaging?

  The device data does not mention any specific MRI safety considerations, but it explicitly states there are no noted MRI safety concerns. However, since these blankets are radiopaque and designed for CT imaging, they should not be used in MRI settings unless confirmed safe by your facility’s MRI safety protocols. Always verify compatibility with your MRI equipment and follow local guidelines.