CT/T Datalink-B7875 Aa/B7875 Ab

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

510(k) Number

K811227 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

• Senograph Ds, Senograph Essenstial

  Class II

  FDA 510(k) K103485 Active Cleared 6 Oct 2011

• Senographe Ds, Senographe Essential

  Class II

  FDA 510(k) K110798 Active Cleared 22 Dec 2011

• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

• Series 620 Rectal Probe Cover

  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

See all devices from General Electric Co. →

• What is the CT/T Datalink-B7875 AA/B7875 AB used for?

  The CT/T Datalink-B7875 AA/B7875 AB is a CT/Telemetry Interface Device designed to bridge communication between CT scanners and external systems. It ensures that imaging data from CT scanners can be transmitted to diagnostic and archival systems, improving compatibility and efficiency in radiology workflows. This is particularly useful in settings where multiple systems need to integrate seamlessly for streamlined patient care and data management.

• How is the CT/T Datalink-B7875 AA/B7875 AB supplied and is it reusable?

  The device is supplied as a standalone interface unit, meaning it is not packaged with additional components like cables or adapters beyond what is necessary for its core function. It is classified as a reusable component, which means it does not require sterilization between uses. This makes it cost-effective for radiology departments, as it can be utilized repeatedly without disposal or reprocessing.

• Are there different models or configurations for the CT/T Datalink-B7875?

  Yes, the CT/T Datalink-B7875 comes in two model variants: AA and AB. These variants likely represent specific configurations or software versions tailored to different system requirements or workflows. While the physical specifications are not detailed, the distinction between AA and AB suggests compatibility with varying setups or updates in radiology infrastructure.

• Is the CT/T Datalink-B7875 AA/B7875 AB safe for use in MRI environments?

  The provided data does not classify the CT/T Datalink-B7875 AA/B7875 AB as MRI-safe or MRI-unsafe. If MRI compatibility is a requirement for your facility, additional verification or testing may be necessary to ensure safe use in proximity to MRI equipment. Always consult your facility’s MRI safety protocols before integrating new devices.

• What regulatory pathway does the CT/T Datalink-B7875 AA/B7875 AB follow?

  The CT/T Datalink-B7875 AA/B7875 AB was reviewed by the FDA’s Radiology (RA) Advisory Committee in 1981 and received traditional 510(k) clearance under the designation K811227. This clearance pathway confirms that the device is considered substantially equivalent to a legally marketed predicate device for its intended use as a medical imaging peripheral. The device remains compliant with traditional clearance requirements.