Digitron 2, Digital Substraction Angio. System
FDA 510(k) K883072 · Siemens Gammasonics, Inc.
510(k) numberK883072
Submission
- Device name
- Digitron 2, Digital Substraction Angio. System
- Applicant
- Siemens Gammasonics, Inc.
Des Plaines, IL, US - Received
- July 20, 1988
- Decision date
- September 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Digitron 2, Digital Substraction Angio. System cleared by the FDA?
Digitron 2, Digital Substraction Angio. System (K883072) received a 510(k) decision of Substantially Equivalent on September 14, 1988, 56 days after the submission was received.
What is the product code of K883072?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.