Digitron 2, Digital Substraction Angio. System

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

510(k) Number

K883072 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Multispect 3 Triple Detector Camera System

  Class II

  FDA 510(k) K911078 Active Cleared 17 Jun 1991

• Sienet Image Display Workstations, Image Acquisiti

  Class II

  FDA 510(k) K920319 Active Cleared 20 Oct 1992

• Carbon Fiber Pallet

  Class I

  FDA 510(k) K934766 Active Cleared 18 Feb 1994

• Ect (Emmission Computed Tomography) Carbon Fib Pal

  Class I

  FDA 510(k) K903767 Active Cleared 7 Sep 1990

• Gamma Camera

  Class I

  FDA 510(k) K810974 Active Cleared 13 May 1981

• Siemens Pacs/I-a

  Class II

  FDA 510(k) K880690 Active Cleared 31 Oct 1988

See all devices from Siemens Gammasonics, Inc. →

• What is the Digitron 2 Digital Subtraction Angiography System used for?

  The Digitron 2 Digital Subtraction Angiography System is designed for imaging blood vessels to improve diagnostic clarity. It uses digital subtraction angiography (DSA), a technique that subtracts a pre-contrast image from a post-contrast image, to highlight vascular structures. This aids in identifying and evaluating conditions such as stenosis, aneurysms, or vascular malformations during interventional and diagnostic radiology procedures.

• Is the Digitron 2 a reusable or single-use device?

  The Digitron 2 is a reusable medical device. As a reusable system, it requires proper calibration and maintenance to ensure consistent imaging accuracy and reliability over time. Regular servicing is essential to uphold performance standards for clinical use.

• What regulatory approval does the Digitron 2 hold?

  The Digitron 2 Digital Subtraction Angiography System is regulated under the FDA 510(k) clearance pathway, with the clearance number K883072. It falls under the classification of System, X-Ray, Angiographic, regulated by FDA regulation number 892.1600. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device.

• How is the Digitron 2 supplied and maintained?

  The Digitron 2 is supplied as a complete reusable system, intended for use in radiology departments. Since it is reusable, it must be regularly calibrated and serviced by trained technicians to ensure optimal performance. Maintenance protocols are critical to prevent degradation in imaging quality and to comply with regulatory requirements for medical imaging devices.

• Does the Digitron 2 require any special storage conditions?

  The device data does not specify special storage conditions beyond standard environmental controls for medical imaging equipment. It should be stored in a clean, dry environment, protected from physical damage and extreme temperatures. Proper storage ensures longevity and reliability of the system for clinical use.