Imatron C-100 Ultrafast CT Scanner

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

510(k) Number

K872615 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ebt Ultrafast CT Scanner System; C-100, C-150, C-150LXP or C-150XP Scanner Systems; Electron Beam Scanner System; Electr

  Class II

  FDA 510(k) K001550 Active Cleared 11 Dec 2000

• Computed Cinetomography Scanner, Model C-100

  Not classified

  FDA 510(k) K828669 Active Cleared 14 Jan 1983

• Imatron Ultra Access Workstation with Cardiac Software Extensions

  Class II

  FDA 510(k) K972903 Active Cleared 4 Nov 1997

• Ebt Ultrafast CT Scanner System; Ultrafast CT Scanner System; C-100, C-150. C-150LXP or C-150XP Scanner Systems; Electro

  Class II

  FDA 510(k) K000359 Active Cleared 17 Mar 2000

• C-150 Ultrafast CT Scanner

  Class II

  FDA 510(k) K913352 Active Cleared 29 Nov 1991

• Ultrafast CT Scanner; Ebt CT Scanner, Evolution

  Class II

  FDA 510(k) K972879 Active Cleared 15 Oct 1997

See all devices from Imatron, Inc. →

• What is the Imatron C-100 Ultrafast CT Scanner designed for?

  The Imatron C-100 Ultrafast CT Scanner is specifically designed for rapid acquisition of cross-sectional images of the body. Its electron beam technology allows for faster scanning compared to traditional CT systems, reducing motion artifacts and improving the clarity of internal structures. This makes it particularly useful in radiology departments for capturing detailed images of moving organs or patients with limited breath-holding capacity.

• How is the Imatron C-100 supplied and maintained?

  The Imatron C-100 is supplied as a reusable medical system, meaning it is intended for repeated use within healthcare facilities. To ensure accurate imaging performance, it requires regular maintenance and calibration. Proper upkeep is essential to sustain its high-speed scanning capabilities and reliability over time.

• Is the Imatron C-100 Ultrafast CT Scanner single-use or reusable?

  The Imatron C-100 is explicitly designed as a reusable medical device. Unlike single-use systems, it is built for long-term deployment in radiology departments, provided it undergoes routine maintenance and calibration to meet performance standards.

• What regulatory clearance does the Imatron C-100 hold?

  The Imatron C-100 Ultrafast CT Scanner holds FDA 510(k) clearance under the K-number K872615, classified under product code JAK for radiology applications. It was cleared in 1987 and is considered substantially equivalent to prior-generation devices. The clearance was reviewed by the Radiology (RA) Advisory Committee.

• Does the Imatron C-100 require special storage conditions?

  While the device itself does not have explicit sterility requirements (as it is reusable), proper storage is critical to prevent environmental contamination and ensure operational integrity. It should be stored in a clean, controlled environment away from direct sunlight, extreme temperatures, and excessive humidity. Regular maintenance checks should also be documented to confirm readiness for use.