| Device Type ID | 817 |
| Device Name | Display, Cathode-ray Tube, Medical |
| Regulation Description | Medical Cathode-ray Tube Display. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 817 |
| Device | Display, Cathode-ray Tube, Medical |
| Product Code | DXJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Cathode-ray Tube Display. |
| CFR Regulation Number | 870.2450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BARCO NV | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDUSA MEDICAL TECHNOLOGIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP DEUTSCHLAND GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZOLL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Monitor | 2 |
Unsealed Device Packaging | 2 |
Device Packaging Compromised | 2 |
Low Readings | 2 |
No Display / Image | 2 |
Smoking | 1 |
Use Of Device Problem | 1 |
Application Program Problem: Dose Calculation Error | 1 |
Loss Of Data | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Device Operates Differently Than Expected | 1 |
Wireless Communication Problem | 1 |
Failure To Power Up | 1 |
Telemetry Discrepancy | 1 |
Electrical Shorting | 1 |
Improper Alarm | 1 |
Device Alarm System | 1 |
Charred | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Split | 1 |
| Total Device Problems | 26 |