Ecat Scintron PET

FDA 510(k) K130269 · Miegmbh

Substantially Equivalent

510(k) numberK130269

Submission

Device name
Ecat Scintron PET
Applicant
Miegmbh
Seth, DE
Received
February 4, 2013
Decision date
April 19, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPS – System, Tomography, Computed, Emission
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1200
Specialty
Radiology

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K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special Siemens Medical Solutions USA, Inc.05/21/2026SE
K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional Shanghai United Imaging Healthcare Co., Ltd.04/03/2026SE
K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional Shanghai United Imaging Healthcare Co., Ltd.02/13/2026SE
K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special Spectrum Dynamics Medical, Ltd.01/13/2026SE
K253844AnyScan 3.0 NM Scanner FamilyKPS · Traditional Mediso Medical Imaging Systems, Ltd.12/30/2025SE
K251370Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional Canon Medical Systems Corporation12/01/2025SE
K251401PennPET Explorer Positron Emission TomographKPS · Traditional Trustees of the University of Pennsylvania11/25/2025SE
K252477Hybrid Viewer (00859873006240)KPS · Special Hermes Medical Solutions AB09/09/2025SE

More from Hermes Medical Solutions AB

510(k)DeviceDecision
K201807AncorisKPS · Traditional 08/27/2020SE
K101768Mie Scintron Gamma Camera SystemsKPS · Traditional 10/05/2010SE
K101013Modification to Scintron IVKPS · Special 06/07/2010SE

Questions and answers

When was Ecat Scintron PET cleared by the FDA?

Ecat Scintron PET (K130269) received a 510(k) decision of Substantially Equivalent on April 19, 2013, 74 days after the submission was received.

What is the product code of K130269?

The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.