ClearanceBrief
510(k) K093514 ยท KPS System, Tomography, Computed, Emission

DISCOVERY MODEL NM/CT 670

ApplicantGe Medical Systems F.I. Haifa, Tirat Hacarmel, IL
DecisionSubstantially Equivalent, Dec 10, 2009
ReceivedNov 13, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K093514

DateFirm and productCodeLinked 510(k)
Jan 10, 2025GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
Open, Classified
KPSNone listed
Jan 10, 2025GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
Open, Classified
KPSNone listed
Jan 10, 2025GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Open, Classified
KPSNone listed
Jan 10, 2025GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Open, Classified
KPSNone listed
Feb 8, 2023GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO,
Open, Classified
KPSNone listed
May 11, 2021GE Healthcare, LLC
NM/CT 870 DR Nuclear Medicine / CT Scanners
Open, Classified
KPSNone listed
Dec 10, 2020GE Healthcare, LLC
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately traine
Terminated
KPSNone listed
Aug 14, 2020GE Healthcare, LLC
Discovery 670 DR Model # H3100BT
Terminated
KPSNone listed
Aug 14, 2020GE Healthcare, LLC
Discovery NM670 Pro Model # H3100XB
Terminated
KPSNone listed
Aug 14, 2020GE Healthcare, LLC
NM/CT 870 DR Model # H3100AS
Terminated
KPSNone listed
Mar 20, 2019GE Healthcare, LLC
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing o
Terminated
JAKNone listed
Mar 20, 2019GE Healthcare, LLC
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of
Terminated
JAKNone listed
Mar 20, 2019GE Healthcare, LLC
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases
Terminated
JAKNone listed
May 24, 2018GE Healthcare, LLC
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders s
Completed
KPSNone listed
May 24, 2018GE Healthcare, LLC
Discovery NM/CT 670 ES, model 5376204-70-57
Completed
KPSNone listed
May 24, 2018GE Healthcare, LLC
Discovery NM/CT 670 Pro, model 5376204-70-54
Completed
KPSNone listed
May 19, 2017GE Healthcare, LLC
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
Terminated
KPSNone listed
Nov 20, 2013GE Healthcare, LLC
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professio
Terminated
KPSNone listed
Jul 24, 2013GE Healthcare, LLC
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained hea
Terminated
KPSNone listed
Oct 23, 2012GE Healthcare, LLC
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a
Terminated
KPSNone listed
Feb 27, 2012GE Healthcare, LLC
GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a
Terminated
KPSNone listed

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