Philips IntelliSite Pathology Solution
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192259 FDA 510(k)
- FDA Product Code
- PSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.3700 FDA 510(k)
- Regulation Number
- 864.3700 FDA 510(k)
- Advisory Committee
- Pathology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Philips IntelliSite Pathology Solution is a Whole Slide Imaging System intended for use in pathology. It is designed to digitize glass slides for viewing, managing, and interpreting pathology specimens.
The device is supplied as a reusable system and has received FDA 510(k) clearance under K192259 and subsequent clearances. It is classified as a Class 2 medical device with product code PSY and is regulated under regulation number 864.3700 for use in pathology settings.
Frequently asked questions
What is the Philips IntelliSite Pathology Solution intended for?
The Philips IntelliSite Pathology Solution is a Whole Slide Imaging System intended for use in pathology to digitize glass slides for viewing, managing, and interpreting pathology specimens, as stated in the device description.
How is the Philips IntelliSite Pathology Solution supplied and is it reusable or single-use?
The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not as a single-use disposable product.
What regulatory pathway was used for the Philips IntelliSite Pathology Solution and what is its classification?
The device received FDA 510(k) clearance under K192259 and is classified as a Class 2 medical device with product code PSY, regulated under 864.3700 for pathology use.
What does the FDA 510(k) clearance K192259 indicate about the Philips IntelliSite Pathology Solution?
The K192259 clearance indicates the device was found substantially equivalent to a legally marketed predicate device, based on the decision description 'Substantially Equivalent' and decision code 'SESE' in the device data.
What is the product code and regulation number for the Philips IntelliSite Pathology Solution?
The device has product code PSY and is regulated under regulation number 864.3700, as explicitly listed in the openfda and specifications fields of the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K192259 FDA 510(k) - Philips IntelliSite Pathology Solution, Philips IntelliSite Pathology Solution 510(k) K241871 - fda.report, K243871 FDA 510(k) - Philips IntelliSite Pathology Solution 5.1
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192259 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Electronics Nederland B.V.
Sources (1)
- FDA 510(k) K192259 24 fields · synced Sep 19, 2026