FDA 510(k)

MONAD NUCLEAR IMAGING SYSTEM

K-Number: K923044 · 1992-08-27

ApplicantTrionix Research Laboratory, Inc.

Decision Date1992-08-27

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MONAD NUCLEAR IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trionix Research Laboratory, Inc.. It received FDA 510(k) clearance on 1992-08-27 under 510(k) number K923044. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONAD NUCLEAR IMAGING SYSTEM?

MONAD NUCLEAR IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-08-27. The listed applicant is Trionix Research Laboratory, Inc.. The 510(k) number is K923044.

When did MONAD NUCLEAR IMAGING SYSTEM receive FDA 510(k) clearance?

MONAD NUCLEAR IMAGING SYSTEM received FDA 510(k) clearance on 1992-08-27, under 510(k) number K923044.

Who is the listed applicant for MONAD NUCLEAR IMAGING SYSTEM?

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

What is the FDA product code for MONAD NUCLEAR IMAGING SYSTEM?

The FDA product code for MONAD NUCLEAR IMAGING SYSTEM is KPS.

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Other records listing Trionix Research Laboratory, Inc. as applicant

K964438511 KEV COLLIMATOR K962481QUASAR RECOVERY IMAGING PACKAGE K964268TRIAD 88 NUCLEAR IMAGING SYSTEM K964265CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM K964267MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM K964266BIAD NUCLEAR IMAGING SYSTEM

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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.