Angioskip System, X-Ray, Angiographic

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

Full name

Angioskip

510(k) Number

K781991 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.via

  Class II

  FDA 510(k) K123375 Active Cleared 20 Nov 2012

• Dental X-Ray Unit

  Class II

  FDA 510(k) K781286 Active Cleared 11 Sep 1978

• Siemens Polydoros 800

  Class I

  FDA 510(k) K820112 Active Cleared 24 Feb 1982

• Opti 110/12/50HSG

  Class I

  FDA 510(k) K810190 Active Cleared 2 Mar 1981

• Optiplanimat

  Class II

  FDA 510(k) K781531 Active Cleared 14 Sep 1978

• Somatom 2

  Class II

  FDA 510(k) K790975 Active Cleared 30 Jul 1979

See all devices from Siemens Corp. →

• What is the Angioskip System used for?

  The Angioskip System is designed specifically for angiographic procedures, enabling radiologists to visualize blood vessels during diagnostic or interventional tasks such as coronary angiography or peripheral vascular imaging. Its primary purpose is to enhance the clarity of vascular structures under X-ray guidance, ensuring accurate assessment and treatment planning.

• Is the Angioskip System reusable or single-use?

  The Angioskip System is supplied as a reusable device. This means it is intended for repeated use in clinical settings like hospitals and radiology clinics, provided it undergoes proper maintenance, cleaning, and sterilization as outlined by the manufacturer to ensure safety and performance.

• What safety considerations should be taken with the Angioskip System?

  The Angioskip System is classified as MRI unsafe, meaning it should not be used or stored in an MRI environment. Additionally, it requires careful handling, regular maintenance, and adherence to manufacturer guidelines to preserve functionality and ensure patient safety during angiographic procedures.

• How is the Angioskip System regulated?

  The Angioskip System is regulated under FDA 510(k) clearance with the reference number K781991. It falls under the regulatory category 892.1600 and was originally submitted to the FDA in 1978. The device is classified as a Class II medical device, indicating it poses moderate risk and requires specific compliance measures.

• What types of clinical settings use the Angioskip System?

  The Angioskip System is intended for use in clinical environments such as hospitals and specialized radiology clinics. Its design supports diagnostic and interventional procedures where high-resolution imaging of blood vessels is critical, including coronary and peripheral vascular assessments.