FDA 510(k)
FDA class 2
Unknown
🇳🇱 Netherlands
Philips IntelliSite Pathology Solution
K Number: DEN160056
·
Decision Apr 12, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
18
Applicant Total
104
Review Days
132
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Basic Information
- Device Name
- Philips IntelliSite Pathology Solution
- K Number
- DEN160056
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 864.3700
- Medical Specialty
- Pathology
- Decision
- Unknown
- Applicant
- Philips Medical Systems Nederland B.V.
- Date Received
- December 1, 2016
- Decision Date
- April 12, 2017
- Product Code
- PSY
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| PSY | Whole Slide Imaging System | FDA class 2 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PSY), ordered by most recent decision date.
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