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FDA 510(k)

IMAGER 2000 REAL TIME SYSTEM

K-Number: K811842 · 1981-11-20

ApplicantSiemens Gammasonics, Inc.
Decision Date1981-11-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGER 2000 REAL TIME 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 1981-11-20 under 510(k) number K811842. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGER 2000 REAL TIME SYSTEM?

IMAGER 2000 REAL TIME SYSTEM is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K811842.

When did IMAGER 2000 REAL TIME SYSTEM receive FDA 510(k) clearance?

IMAGER 2000 REAL TIME SYSTEM received FDA 510(k) clearance on 1981-11-20, under 510(k) number K811842.

Who is the listed applicant for IMAGER 2000 REAL TIME 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 IMAGER 2000 REAL TIME SYSTEM?

The FDA product code for IMAGER 2000 REAL TIME SYSTEM is IYO.

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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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