Device |
camera, scintillation (gamma) |
Regulation Medical Specialty |
Radiology |
Review Panel |
Radiology |
Product Code | IYX |
Premarket Review |
Office of In Vitro Diagnostics and Radiological Health
(OIR)
Division of Radiological Health
(DRH)
|
Submission Type |
510(k)
|
Regulation Number |
892.1100
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review
|
Accredited Persons
|