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Mie Scintron Gamma Camera Systems

by Miegmbh

510(k) K101768

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 NumberK101768 Date5 Oct 2010ClearedStatusActive

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  • Withdrawn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, 6 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 MIE SCINTRON GAMMA CAMERA SYSTEMS is a gamma camera system used in nuclear medicine imaging. It detects gamma ray radionuclide distribution in patients and performs planar, dynamic, whole-body, and SPECT acquisitions.

The system acquires, reviews, and processes nuclear medicine data to assist clinicians in diagnostic interpretation. It is used in clinical nuclear medicine settings by trained personnel and is supplied as a remanufactured system integrated with a MiE workstation.

Other devices from Miegmbh

Questions

AI-generated answers, 6 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 MIE SCINTRON GAMMA CAMERA SYSTEMS used for?

    The MIE SCINTRON GAMMA CAMERA SYSTEMS is used in nuclear medicine imaging to detect gamma ray radionuclide distribution in patients and perform planar, dynamic, whole-body, and SPECT acquisitions, assisting clinicians in diagnostic interpretation.

  • How is the MIE SCINTRON GAMMA CAMERA SYSTEMS supplied?

    The MIE SCINTRON GAMMA CAMERA SYSTEMS is supplied as a remanufactured system integrated with a MiE workstation for use in clinical nuclear medicine settings by trained personnel.

  • What regulatory pathway was used for the MIE SCINTRON GAMMA CAMERA SYSTEMS?

    The MIE SCINTRON GAMMA CAMERA SYSTEMS received authorization through the FDA 510(k) pathway, with a decision of substantially equivalent based on the traditional clearance process.