FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALAXY PLUS
K Number: K132921
·
Decision Jan 17, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
3
Review Days
122
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Basic Information
- Device Name
- GALAXY PLUS
- K Number
- K132921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medien International Co, Ltd.
- Date Received
- September 17, 2013
- Decision Date
- January 17, 2014
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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