NQN · Class II · 21 CFR 864.1860

FDA Product Code NQN: Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.

Leading manufacturers include Ventana Medical Systems, Inc..

15
Total
15
Cleared
242d
Avg days
2004
Since

FDA 510(k) Cleared Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity Devices (Product Code NQN)

15 devices
1–15 of 15
Cleared Mar 20, 2014
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465
Ventana Medical Systems, Inc.
Pathology · 24d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515
Ventana Medical Systems, Inc.
Pathology · 268d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516
Ventana Medical Systems, Inc.
Pathology · 492d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143
Ventana Medical Systems, Inc.
Pathology · 427d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872
Ventana Medical Systems, Inc.
Pathology · 293d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869
Ventana Medical Systems, Inc.
Pathology · 248d

About Product Code NQN - Regulatory Context