FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STARCAM 4000
K Number: K904174
·
Decision Jan 4, 1991
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
254
Review Days
116
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Basic Information
- Device Name
- STARCAM 4000
- K Number
- K904174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- September 10, 1990
- Decision Date
- January 4, 1991
- Product Code
- IYX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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