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Philips Herceptest Digital Score

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130021

by Philips Medical Systems Nederland B.V.

Identifiers

510(k) Number
K130021 FDA 510(k)
FDA Product Code
OEO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.1860 FDA 510(k)
Regulation Number
864.1860 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Philips Herceptest Digital Score is an automated digital image manual interpretation microscope used in hematology. It is designed to assess HER2 protein expression in breast cancer tissue samples.

The device is supplied as a digital diagnostic tool intended for use as an accessory to the Dako HercepTest™ to aid in the detection and semi-quantitative measurement of HER2/neu in formalin-fixed, paraffin-embedded neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. It was cleared through the FDA 510(k) pathway on September 19, 2013, and is classified as a Class 2 device.

Frequently asked questions

What is the Philips Herceptest Digital Score used for?

The Philips Herceptest Digital Score is supplied as a digital diagnostic tool intended for use as an accessory to the Dako HercepTest™ system, enabling interpretation of stained tissue samples on a computer monitor.

Is the Philips Herceptest Digital Score a single-use or reusable device?

The Philips Herceptest Digital Score is a reusable automated digital image manual interpretation microscope, as it is designed for repeated use in interpreting HER2-stained tissue samples via digital imaging on a computer monitor.

How was the Philips Herceptest Digital Score cleared for market?

The Philips Herceptest Digital Score was cleared through the FDA 510(k) pathway on September 19, 2013, under submission K130021, and is classified as a Class 2 medical device.

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: Philips Herceptest Digital Score - Philips Medical Systems Nederland ..., PHILIPS HERCEPTEST DIGITAL SCORE (K130021) — FDA 510 (k) | Innolitics, Philips Herceptest Digital Score 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.

Sources (1)

  • FDA 510(k) K130021 24 fields · synced Oct 6, 2026