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Microdelta, Gated Single Photon (SPECT) Package

by Siemens Gammasonics, Inc.

510(k) K900892

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900892 Date2 May 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Microdelta, Gated Single Photon (SPECT) Package is a system for computed emission tomography, designed for single photon emission computed tomography imaging. It is classified as a Class II device under product code KPS and is intended for use in radiology applications.

This device is manufactured by Siemens Gammasonics, Inc. and was cleared by the FDA under 510(k) number K900892 in 1990. The system includes various components with specific FEI numbers and registration numbers as listed in the regulatory documentation. No information regarding sterility, single-use status, MRI compatibility, or storage conditions is provided in the device data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Microdelta Gated Single Photon (SPECT) Package used for?

    The Microdelta Gated Single Photon (SPECT) Package is a system designed for single photon emission computed tomography imaging, intended for use in radiology applications to create detailed images of internal body structures.

  • What is the regulatory classification of the Microdelta Gated Single Photon (SPECT) Package?

    This device is classified as a Class II medical device under product code KPS and was cleared by the FDA under 510(k) number K900892 in 1990, with a decision code of SESE indicating substantial equivalence.

  • Is the Microdelta Gated Single Photon (SPECT) Package sterile or single-use?

    The device data does not provide information regarding sterility or single-use status. The system includes various components with specific FEI numbers and registration numbers as listed in the regulatory documentation.

  • What components are included in the Microdelta Gated Single Photon (SPECT) Package?

    The system includes various components with specific FEI numbers and registration numbers as listed in the regulatory documentation, though the specific components are not detailed in the provided information.