D.I.V.A.S. Angiographic System

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

Full name

D.I.V.A.S.

510(k) Number

K812238 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ibis II

  Class II

  FDA 510(k) K812963 Active Cleared 24 Nov 1981

• Comptar III

  Class I

  FDA 510(k) K813051 Active Cleared 24 Nov 1981

• Process 100 St

  Class I

  FDA 510(k) K833846 Active Cleared 16 Dec 1983

• Verasun Radiation Therapy Simulation System

  Not classified

  FDA 510(k) K837336 Active Cleared 29 Apr 1983

• Sonel 3000A

  Class II

  FDA 510(k) K833223 Active Cleared 9 May 1984

• Maximax - 4

  Class II

  FDA 510(k) K841649 Active Cleared 5 Jun 1984

See all devices from Cgr Medical Corp. →

• Is the D.I.V.A.S. Angiographic System designed for single-use or can it be reused in clinical settings?

  The D.I.V.A.S. Angiographic System is explicitly described as a reusable medical device. Since it is not labeled as single-use, it is intended for repeated use in radiology departments after proper cleaning, maintenance, and sterilization procedures.

• What types of vascular abnormalities can the D.I.V.A.S. Angiographic System help identify during angiographic procedures?

  The D.I.V.A.S. Angiographic System is designed to provide high-quality X-ray imaging for visualizing blood vessels, enabling detailed assessment of vascular structures. This allows clinicians to identify abnormalities such as blockages (stenosis) or aneurysms during angiographic procedures.

• How is the D.I.V.A.S. Angiographic System regulated by the FDA, and what does this mean for its use in hospitals?

  The D.I.V.A.S. Angiographic System is classified as a Class II device under FDA regulations (892.1600) and has received FDA 510(k) clearance through a traditional review process. This means it has been deemed substantially equivalent to a legally marketed device and is approved for use in radiology departments for angiographic imaging.

• Are there specific storage conditions mentioned for the D.I.V.A.S. Angiographic System, or is it left to the discretion of the facility?

  The provided data does not specify any particular storage conditions for the D.I.V.A.S. Angiographic System. Since it is reusable, facilities will need to follow their own protocols for maintenance, cleaning, and storage to ensure proper functionality and safety.

• What is the primary medical specialty for which the D.I.V.A.S. Angiographic System is intended?

  The D.I.V.A.S. Angiographic System is intended for use in the medical specialty of radiology, as indicated by the advisory committee and medical specialty descriptions in the data. It is specifically designed for angiographic procedures within radiology departments.