Product code NQN— Hematology
ARIOL
- Classification name
- Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Total cleared
- 15
- First cleared
- Most recent
FDA classification definition
“Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.”
Market context for product code NQN
FDA has cleared devices under product code NQN between 2004 and 2015, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2014
- 2013
- 2012
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
Top applicants under product code NQN
Recent clearances under product code NQN
- K140957 — GENASIS HIPATH IHC FAMILY
- K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
- K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI)
- K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
- K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
- K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
- K111869 — VIRTUOSO SYSTEM FOR IHC PR (IE2)
- K092333 — PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
- K073677 — SCANSCOPE XT SYSTEM
- K061613 — VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
- K062428 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
- K053520 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
- K050012 — VENTANA IMAGE ANALYSIS SYSTEM
- K033200 — ARIOL
- K031363 — QCA (VERSION 3.1)
Data sourced from openFDA. This site is unofficial and independent of the FDA.