510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K130021Substantially Equivalent

Philips Herceptest Digital Score

Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130021 is the FDA 510(k) clearance record for PHILIPS HERCEPTEST DIGITAL SCORE, a class II device, cleared for Philips Medical Systems Nederland B.V. on under FDA product code OEO (Automated Digital Image Manual Interpretation Microscope). FDA's definition for product code OEO reads: "The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic...". FDA records list 115 510(k) clearances for Philips Medical Systems Nederland B.V., from to . As of , FDA records show no recalls naming K130021.

Clearance record

Decision date
Received
(259 days to decision)
Product code
OEO Automated Digital Image Manual Interpretation Microscope
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Philips Medical Systems Nederland B.V. Veenpluis 4-6, Best Noord-Brabant, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEO

Trailing 12 months

FDA records hold no clearances under product code OEO in the trailing twelve months.

FDA records show no clearances under product code OEO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OEO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260