Mammi

FDA 510(k) K161631 · General Equipment For Medical Imaging

Substantially Equivalent

510(k) numberK161631

Submission

Device name
Mammi
Applicant
General Equipment For Medical Imaging
Valencia, ES
Received
June 13, 2016
Decision date
July 28, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 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

Other 510(k)s with product code KPS

510(k)DeviceApplicantDecision
K261305Micsi-PetKPS · Traditional Microstructure Imaging, Inc.09/11/2026SE
K261427uMI Panvivo (uMI Panvivo M)KPS · Traditional Shanghai United Imaging Healthcare Co., Ltd.07/28/2026SE
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

Questions and answers

When was Mammi cleared by the FDA?

Mammi (K161631) received a 510(k) decision of Substantially Equivalent on July 28, 2016, 45 days after the submission was received.

What is the product code of K161631?

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