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 |