| Device Type ID | 5370 |
| Device Name | System, Tomography, Computed, Emission |
| Regulation Description | Emission Computed Tomography System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5370 |
| Device | System, Tomography, Computed, Emission |
| Product Code | KPS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Emission Computed Tomography System. |
| CFR Regulation Number | 892.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRACCO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIOVASCULAR IMAGING TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CEDARS-SINAI MEDICAL CENTER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DDD-DIAGNOSTIC A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
HERMES MEDICAL SOLUTIONS, AB | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
SIEMENS CAPITAL | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
SIEMENS MEDICAL SOLUTIONS, USA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM DYNAMICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM DYNAMICS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSHIBA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOSHIBA MEDICAL SYSTEMS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Mechanical Problem | 5 |
Positioning Problem | 4 |
Use Of Device Problem | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Device Operates Differently Than Expected | 4 |
Appropriate Term/Code Not Available | 2 |
Break | 2 |
Insufficient Information | 2 |
Leak / Splash | 2 |
Unintended Collision | 2 |
Unintended Movement | 2 |
Device Handling Problem | 2 |
Off-Label Use | 1 |
Protective Measures Problem | 1 |
Misassembly By Users | 1 |
Cover | 1 |
Overheating Of Device | 1 |
Interface | 1 |
Component Falling | 1 |
Device Tipped Over | 1 |
Activation, Positioning Or Separation Problem | 1 |
Degraded | 1 |
Smoking | 1 |
Detector | 1 |
Inadequate Service | 1 |
Human-Device Interface Problem | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 58 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare | II | Sep-21-2015 |
| 2 | GE Healthcare | II | Mar-13-2015 |
| 3 | GE Healthcare, LLC | II | Jan-09-2019 |
| 4 | GE Healthcare, LLC | II | Dec-13-2018 |
| 5 | GE Healthcare, LLC | I | Nov-14-2018 |
| 6 | GE Healthcare, LLC | II | Jul-31-2018 |
| 7 | GE Healthcare, LLC | II | Jun-12-2017 |
| 8 | GE Healthcare, LLC | II | Dec-16-2014 |
| 9 | GE Healthcare, LLC | II | Mar-13-2014 |
| 10 | GE Healthcare, LLC | II | Feb-14-2014 |
| 11 | GE Medical Systems, LLC | II | Mar-04-2016 |
| 12 | Philips Medical Systems (Cleveland) Inc | II | Feb-12-2019 |
| 13 | Philips Medical Systems (Cleveland) Inc | II | Oct-31-2018 |
| 14 | Philips Medical Systems (Cleveland) Inc | II | Jul-19-2018 |
| 15 | Philips Medical Systems (Cleveland) Inc | II | Jun-22-2018 |
| 16 | Philips Medical Systems (Cleveland) Inc | II | Apr-17-2018 |
| 17 | Philips Medical Systems (Cleveland) Inc | II | Feb-04-2018 |
| 18 | Philips Medical Systems (Cleveland) Inc | II | Feb-03-2018 |
| 19 | Philips Medical Systems (Cleveland) Inc | II | Apr-06-2017 |
| 20 | Philips Medical Systems (Cleveland) Inc | III | Apr-06-2017 |
| 21 | Philips Medical Systems (Cleveland) Inc | II | Mar-16-2017 |
| 22 | Philips Medical Systems (Cleveland) Inc | II | Feb-10-2017 |
| 23 | Philips Medical Systems (Cleveland) Inc | II | Sep-03-2016 |
| 24 | Philips Medical Systems (Cleveland) Inc | II | Apr-15-2016 |
| 25 | Philips Medical Systems (Cleveland) Inc | II | Feb-26-2016 |
| 26 | Philips Medical Systems (Cleveland) Inc | II | Jul-22-2015 |
| 27 | Philips Medical Systems (Cleveland) Inc | II | Jun-11-2015 |
| 28 | Philips Medical Systems (Cleveland) Inc | II | May-28-2015 |
| 29 | Philips Medical Systems (Cleveland) Inc | II | May-12-2015 |
| 30 | Philips Medical Systems (Cleveland) Inc | II | Jan-26-2015 |
| 31 | Philips Medical Systems (Cleveland) Inc | II | Dec-01-2014 |
| 32 | Philips Medical Systems (Cleveland) Inc | II | Jul-10-2014 |
| 33 | Philips Medical Systems (Cleveland) Inc | II | Jul-02-2014 |
| 34 | Philips Medical Systems (Cleveland) Inc | II | Jun-02-2014 |
| 35 | Philips Medical Systems (Cleveland) Inc | II | Apr-26-2014 |
| 36 | Philips Medical Systems (Cleveland) Inc | II | Apr-16-2014 |
| 37 | Philips Medical Systems (Cleveland) Inc | II | Feb-24-2014 |
| 38 | Philips Medical Systems (Cleveland) Inc | II | Feb-12-2014 |
| 39 | Philips Medical Systems (Cleveland) Inc | II | Feb-04-2014 |
| 40 | Philips Medical Systems, Inc. | II | Dec-12-2014 |
| 41 | Siemens Medical Solutions USA Inc. | II | Feb-28-2017 |
| 42 | Siemens Medical Solutions USA Inc. | II | Jan-10-2017 |
| 43 | Siemens Medical Solutions USA Inc. | II | Jun-21-2016 |
| 44 | Siemens Medical Solutions USA Inc. | II | Jun-15-2016 |
| 45 | Siemens Medical Solutions USA Inc. | II | Aug-05-2015 |
| 46 | Siemens Medical Solutions USA Inc. | II | Dec-16-2014 |
| 47 | Siemens Medical Solutions USA, Inc. | II | Jan-10-2019 |
| 48 | Siemens Medical Solutions USA, Inc. | II | Nov-02-2018 |
| 49 | Siemens Medical Solutions USA, Inc. | II | Oct-18-2018 |
| 50 | Siemens Medical Solutions USA, Inc. | II | May-24-2018 |
| 51 | Siemens Medical Solutions USA, Inc. | II | Nov-16-2017 |
| 52 | Siemens Medical Solutions USA, Inc. | II | Oct-25-2017 |
| 53 | Siemens Medical Solutions USA, Inc. | II | Oct-08-2016 |
| 54 | Siemens Medical Solutions USA, Inc. | II | Mar-25-2016 |
| 55 | Siemens Medical Solutions USA, Inc. | II | Nov-04-2015 |
| 56 | Siemens Medical Solutions USA, Inc. | II | Aug-20-2015 |
| 57 | Siemens Medical Solutions USA, Inc. | II | Mar-19-2015 |
| 58 | Siemens Medical Solutions USA, Inc. | II | Feb-10-2015 |
| 59 | Siemens Medical Solutions USA, Inc. | II | Jan-13-2015 |
| 60 | Siemens Medical Solutions USA, Inc. | II | Jan-06-2015 |
| 61 | Siemens Medical Solutions USA, Inc. | II | Jan-06-2015 |
| 62 | Siemens Medical Solutions USA, Inc. | II | Oct-22-2014 |
| 63 | Siemens Medical Solutions USA, Inc. | II | Sep-29-2014 |
| 64 | Siemens Medical Solutions USA, Inc. | II | Jul-11-2014 |
| 65 | Toshiba American Medical Systems Inc | II | Oct-06-2016 |
| 66 | Toshiba American Medical Systems Inc | II | May-04-2016 |
| 67 | Toshiba American Medical Systems Inc | II | Oct-07-2015 |