ClearanceBrief
510(k) K033254 ยท KPS System, Tomography, Computed, Emission

FORTE GAMMA CAMERA SYSTEM

ApplicantAdac Laboratories, Milpitas CA, US
DecisionSubstantially Equivalent, Oct 22, 2003
ReceivedOct 8, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K033254

DateFirm and productCodeLinked 510(k)
Nov 1, 2019Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn
Terminated
KPSNone listed
Nov 1, 2019Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn
Terminated
KPSNone listed
Nov 1, 2019Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn
Terminated
KPSNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSNone listed

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