| Device Type ID | 5388 |
| Device Name | System, Nuclear Magnetic Resonance Imaging |
| Regulation Description | Magnetic Resonance Diagnostic Device. |
| 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 | 892.1000 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LNH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5388 |
| Device | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Magnetic Resonance Diagnostic Device. |
| CFR Regulation Number | 892.1000 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ASPECT IMAGING LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CANON MEDICAL SYSTEMS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CLEARMRI SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEERFIELD IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIAGNOSOFT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ESAOTE | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ESAOTE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ESAOTE, S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 12 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 13 | |
HEARTVISTA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HITACHI HEALTHCARE AMERICAS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HITACHI MEDICAL SYSTEMS AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
LIAONING KAMPO MEDICAL SYSTEM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOCOIL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NORDICNEUROLAB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARAMED S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 26 | |
SIEMENS CAPITAL | ||
SUBSTANTIALLY EQUIVALENT | 21 | |
SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUZHOU ANKE MEDICAL SYSTEM CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTHETICMR AB | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TIME MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSHIBA | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
TOSHIBA AMERICA MEDICAL SYSTEMS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSHIBA MEDICAL SYSTEMS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 53 |
Use Of Device Problem | 35 |
Insufficient Information | 27 |
Improper Or Incorrect Procedure Or Method | 18 |
Device Issue | 12 |
Device Operates Differently Than Expected | 10 |
Human Factors Issue | 8 |
Magnet | 7 |
Connection Problem | 5 |
Electrical /Electronic Property Problem | 5 |
Appropriate Term/Code Not Available | 4 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 4 |
Thermal Decomposition Of Device | 4 |
Device Handling Problem | 4 |
Coil | 4 |
Patient Device Interaction Problem | 3 |
Computer Software Problem | 3 |
Missing Value Reason | 3 |
Noise, Audible | 3 |
Overheating Of Device | 3 |
Device Stops Intermittently | 3 |
Communication Or Transmission Problem | 3 |
No Apparent Adverse Event | 2 |
Device Displays Incorrect Message | 2 |
Calibration Problem | 2 |
Display Or Visual Feedback Problem | 2 |
Labelling, Instructions For Use Or Training Problem | 2 |
Mechanical Problem | 2 |
Disconnection | 2 |
Image Orientation Incorrect | 2 |
Loose Or Intermittent Connection | 2 |
Table Top | 2 |
Installation-Related Problem | 2 |
System | 2 |
Arcing | 2 |
Electrical Shorting | 2 |
Unintended Movement | 2 |
Poor Quality Image | 1 |
Normal | 1 |
Plug | 1 |
Component Incompatible | 1 |
Off-Label Use | 1 |
Calibration Error | 1 |
Positioning Problem | 1 |
No Device Output | 1 |
Naturally Worn | 1 |
Temperature Problem | 1 |
Controller | 1 |
Circuit Failure | 1 |
Misassembled | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Physical Property Issue | 1 |
Device Operational Issue | 1 |
Disk | 1 |
Fire | 1 |
Fracture | 1 |
Unintended Magnet Quench | 1 |
Difficult To Remove | 1 |
Radiofrequency Interference (RFI) | 1 |
Device Inoperable | 1 |
Misconnection | 1 |
Battery | 1 |
Frame | 1 |
Failure To Fire | 1 |
Compatibility Problem | 1 |
Table | 1 |
| Total Device Problems | 281 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alltech Medical Systems America Inc | I | Feb-18-2015 |
| 2 | Canon Medical System, USA, INC. | II | Oct-22-2018 |
| 3 | Deerfield Imaging | II | Mar-11-2016 |
| 4 | Deerfield Imaging, Inc. | II | May-04-2018 |
| 5 | Esaote S.p.A. | II | Jul-05-2016 |
| 6 | GE Healthcare | II | Nov-10-2015 |
| 7 | GE Healthcare | II | Aug-05-2015 |
| 8 | GE Healthcare | II | Mar-20-2015 |
| 9 | GE Healthcare | I | Feb-18-2015 |
| 10 | GE Healthcare, LLC | II | Jan-07-2019 |
| 11 | GE Healthcare, LLC | II | Feb-10-2017 |
| 12 | GE Healthcare, LLC | II | Sep-02-2016 |
| 13 | GE Healthcare, LLC | II | Jul-06-2016 |
| 14 | GE Healthcare, LLC | II | Jun-08-2016 |
| 15 | GE Healthcare, LLC | II | May-01-2014 |
| 16 | GE Healthcare, LLC | II | Apr-21-2014 |
| 17 | GE Medical Systems, LLC | II | Oct-24-2018 |
| 18 | GE Medical Systems, LLC | II | Oct-15-2018 |
| 19 | GE Medical Systems, LLC | II | Sep-27-2018 |
| 20 | GE Medical Systems, LLC | II | Jul-23-2018 |
| 21 | GE Medical Systems, LLC | II | Aug-02-2017 |
| 22 | GE Medical Systems, LLC | II | Apr-07-2016 |
| 23 | GE Medical Systems, LLC | II | Oct-30-2015 |
| 24 | Hitachi Medical Systems America Inc | II | Jul-18-2018 |
| 25 | Hitachi Medical Systems America Inc | II | Mar-23-2017 |
| 26 | Hitachi Medical Systems America Inc | II | Jan-26-2017 |
| 27 | Hitachi Medical Systems America Inc | II | Sep-02-2014 |
| 28 | MWT Materials, Inc. | II | Jan-21-2016 |
| 29 | Medtronic Navigation | II | Jul-06-2016 |
| 30 | NordicNeuroLab AS | II | Sep-11-2018 |
| 31 | NordicNeuroLab AS | II | Jun-06-2018 |
| 32 | Philips Electronics North America Corporation | II | Apr-18-2018 |
| 33 | Philips Electronics North America Corporation | II | Dec-19-2016 |
| 34 | Philips Electronics North America Corporation | II | Feb-26-2016 |
| 35 | Philips Electronics North America Corporation | II | Jul-22-2015 |
| 36 | Philips Medical Systems Nederlands | II | Feb-22-2019 |
| 37 | Philips Medical Systems Nederlands | II | Jan-08-2019 |
| 38 | Philips Medical Systems, Inc. | II | Nov-23-2015 |
| 39 | Philips Medical Systems, Inc. | II | Oct-19-2015 |
| 40 | Philips Medical Systems, Inc. | II | Mar-20-2015 |
| 41 | Philips Medical Systems, Inc. | II | Jun-24-2014 |
| 42 | Philips Medical Systems, Inc. | II | Jun-18-2014 |
| 43 | Siemens Medical Solutions USA, Inc | II | Apr-10-2017 |
| 44 | Siemens Medical Solutions USA, Inc | II | May-03-2016 |
| 45 | Siemens Medical Solutions USA, Inc | II | Dec-22-2015 |
| 46 | Siemens Medical Solutions USA, Inc | II | Mar-20-2015 |
| 47 | Siemens Medical Solutions USA, Inc | II | May-27-2014 |
| 48 | Toshiba American Medical Systems Inc | II | Jul-06-2016 |