ClearanceBrief
510(k) K163619 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

SIGNA PET/MR

ApplicantGe Medical Systems, LLC, Waukesha WI, US
DecisionSubstantially Equivalent, Feb 14, 2017
ReceivedDec 22, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163619

DateFirm and productCodeLinked 510(k)
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
Open, Classified		 LNHNone listed
Nov 22, 2024GE Medical Systems, LLC
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Open, Classified		 LNHNone listed
Aug 2, 2024GE Medical Systems, LLC
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
Open, Classified		 OUONone listed
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
Open, Classified		 OUONone listed
Jul 12, 2021GE Healthcare, LLC
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Open, Classified		 OUONone listed
Sep 8, 2020GE Healthcare, LLC
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing f
Terminated		 OUONone listed
Aug 2, 2017GE Medical Systems, LLC
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registrati
Terminated		 LNHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.