FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
K Number: K881013
·
Decision Aug 29, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
54
Review Days
172
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Basic Information
- Device Name
- MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
- K Number
- K881013
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Toshiba Medical Systems
- Date Received
- March 10, 1988
- Decision Date
- August 29, 1988
- 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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| K883756 | TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM | Nov 14, 1988 | Substantially Equivalent |