| Device Type ID | 5342 |
| Device Name | System, X-ray, Angiographic |
| Regulation Description | Angiographic X-ray 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 | 892.1600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IZI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5342 |
| Device | System, X-ray, Angiographic |
| Product Code | IZI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic X-ray System. |
| CFR Regulation Number | 892.1600 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT - WITH DRUG | 1 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT - WITH DRUG | 1 | |
HAMAMATSU PHOTONICS, K.K. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEICA MICROSYSTEMS CMS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 1 | |
LEICA MICROSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |
MIVENION GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIE MEDICAL IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIE MEDICAL IMAGING B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 45 |
No Apparent Adverse Event | 11 |
Missing Value Reason | 4 |
Component Falling | 3 |
Detachment Of Device Component | 3 |
Loss Of Power | 3 |
Device Displays Incorrect Message | 3 |
Device Operates Differently Than Expected | 3 |
Device Operational Issue | 2 |
Bent | 2 |
Device Stops Intermittently | 2 |
Device Inoperable | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Power Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Computer Operating System Problem | 2 |
System | 2 |
Repair | 1 |
Use Of Incorrect Control Settings | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Unintended Movement | 1 |
Loose Or Intermittent Connection | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Temperature Problem | 1 |
Computer Hardware | 1 |
Foot Pedal | 1 |
Electrical /Electronic Property Problem | 1 |
Self-Activation Or Keying | 1 |
Appropriate Term/Code Not Available | 1 |
Use Of Device Problem | 1 |
Radiation Overexposure | 1 |
Data Problem | 1 |
CRT (Cathode Ray Tube) | 1 |
Failure To Fire | 1 |
Foot Switch | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 112 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare | II | Jul-03-2015 |
| 2 | GE Healthcare, LLC | II | Dec-23-2016 |
| 3 | GE Healthcare, LLC | II | Dec-16-2014 |
| 4 | GE Healthcare, LLC | II | Jan-28-2014 |
| 5 | GE Medical Systems, LLC | II | Dec-12-2015 |
| 6 | NOVADAQ TECHNOLOGIES INC. | II | Sep-08-2016 |
| 7 | NeuroLogica Corporation | II | Nov-10-2015 |
| 8 | Novadaq Technologies, Inc. | III | Dec-01-2014 |
| 9 | Philips Electronics North America Corporation | II | Sep-21-2018 |
| 10 | Philips Electronics North America Corporation | II | Jan-20-2017 |
| 11 | Philips Electronics North America Corporation | II | Jan-20-2017 |
| 12 | Philips Electronics North America Corporation | II | Aug-01-2016 |
| 13 | Philips Electronics North America Corporation | II | Feb-16-2016 |
| 14 | Philips Electronics North America Corporation | II | Jan-30-2016 |
| 15 | Philips Medical Systems Nederlands | II | May-03-2018 |
| 16 | Philips Medical Systems, Inc. | II | Mar-31-2016 |
| 17 | Philips Medical Systems, Inc. | II | Mar-02-2015 |
| 18 | Philips Medical Systems, Inc. | II | Feb-26-2015 |
| 19 | Philips North America, LLC | II | Mar-23-2019 |
| 20 | Shimadzu Medical Systems | II | Jun-14-2018 |
| 21 | Shimadzu Medical Systems | II | May-08-2014 |
| 22 | Shimadzu Medical Systems Usa Com | II | Feb-27-2019 |
| 23 | Siemens Medical Solutions USA, Inc | II | Dec-05-2018 |
| 24 | Siemens Medical Solutions USA, Inc | II | Nov-14-2018 |
| 25 | Siemens Medical Solutions USA, Inc | II | Feb-23-2018 |
| 26 | Siemens Medical Solutions USA, Inc | II | Aug-29-2017 |
| 27 | Siemens Medical Solutions USA, Inc | II | Jul-14-2017 |
| 28 | Siemens Medical Solutions USA, Inc | II | Mar-30-2017 |
| 29 | Siemens Medical Solutions USA, Inc | II | Mar-14-2017 |
| 30 | Siemens Medical Solutions USA, Inc | II | Aug-11-2016 |
| 31 | Siemens Medical Solutions USA, Inc | II | Aug-05-2016 |
| 32 | Siemens Medical Solutions USA, Inc | II | Mar-31-2016 |
| 33 | Siemens Medical Solutions USA, Inc | II | Mar-31-2016 |
| 34 | Siemens Medical Solutions USA, Inc | II | Mar-31-2016 |
| 35 | Siemens Medical Solutions USA, Inc | II | Aug-05-2015 |
| 36 | Siemens Medical Solutions USA, Inc | II | Jan-14-2015 |
| 37 | Siemens Medical Solutions USA, Inc | II | Dec-01-2014 |
| 38 | Siemens Medical Solutions USA, Inc | II | Nov-07-2014 |
| 39 | Siemens Medical Solutions USA, Inc | II | Sep-24-2014 |
| 40 | Siemens Medical Solutions USA, Inc | II | Sep-22-2014 |
| 41 | Siemens Medical Solutions USA, Inc | II | Mar-31-2014 |
| 42 | Siemens Medical Solutions USA, Inc | II | Mar-22-2014 |
| 43 | Siemens Medical Solutions USA, Inc | II | Feb-24-2014 |