FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI GAMMA CAMERA, MODEL MGC-500
K Number: K040587
·
Decision May 14, 2004
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
2
Review Days
70
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Basic Information
- Device Name
- MINI GAMMA CAMERA, MODEL MGC-500
- K Number
- K040587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acrorad Co., Ltd.
- Date Received
- March 5, 2004
- Decision Date
- May 14, 2004
- 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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Other Clearances by Acrorad Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K043293 | MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U | Dec 17, 2004 | Substantially Equivalent |