| Device Type ID | 5355 |
| Device Name | System, Therapeutic, X-ray |
| Regulation Description | X-ray Radiation Therapy 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 | 892.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JAD |
| 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 | 5355 |
| Device | System, Therapeutic, X-ray |
| Product Code | JAD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | X-ray Radiation Therapy System. |
| CFR Regulation Number | 892.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICAD INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SENSUS HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XSTRAHL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Device Displays Incorrect Message | 2 |
Patient Device Interaction Problem | 2 |
Radiation Underexposure | 1 |
Output Problem | 1 |
Output Below Specifications | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Carl Zeiss Meditec AG | II | Oct-02-2017 |