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FDA 510(k)

MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM

K-Number: K905074 · 1991-06-21

ApplicantSiemens Gammasonics, Inc.
Decision Date1991-06-21
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM 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 1991-06-21 under 510(k) number K905074. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM?

MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM is a medical device that received FDA 510(k) clearance on 1991-06-21. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K905074.

When did MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM receive FDA 510(k) clearance?

MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM received FDA 510(k) clearance on 1991-06-21, under 510(k) number K905074.

Who is the listed applicant for MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM?

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 MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM?

The FDA product code for MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM is IYX.

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Related Devices (Code: IYX)

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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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