FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Philips IntelliSite Pathology Solution
K Number: K192259
·
Decision Sep 20, 2019
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
18
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- Philips IntelliSite Pathology Solution
- K Number
- K192259
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.3700
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Electronics Nederland B.V.
- Date Received
- August 21, 2019
- Decision Date
- September 20, 2019
- 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 |
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Other Clearances by Philips Electronics Nederland B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K171055 | Philips BlueControl | Jul 6, 2017 | Substantially Equivalent |