FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PHILIPS MICRODOSE
K Number: K120255
·
Decision Apr 19, 2012
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- PHILIPS MICRODOSE
- K Number
- K120255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Digital Mammography Sweden AB
- Date Received
- January 27, 2012
- Decision Date
- April 19, 2012
- Product Code
- MUE
- 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 |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
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