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FDA 510(k)

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM

K-Number: K883072 · 1988-09-14

ApplicantSiemens Gammasonics, Inc.
Decision Date1988-09-14
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1988-09-14 under 510(k) number K883072. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM?

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM is a medical device that received FDA 510(k) clearance on 1988-09-14. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K883072.

When did DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM receive FDA 510(k) clearance?

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM received FDA 510(k) clearance on 1988-09-14, under 510(k) number K883072.

Who is the listed applicant for DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM?

The FDA 510(k) record lists Siemens Gammasonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM?

The FDA product code for DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM is IZI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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