510(k) K033200
- Device
- ARIOL
- Applicant
- APPLIED IMAGING CORP.
- 510(k) number
- K033200
- Product code
- NQN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-18
- Date received
- 2003-10-02
- Regulation
- 864.1860
- Classification name
- Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANE OATES
- Address
- 2380 Walsh Ave., Bldg.B Santa Clara CA US 95051 95051
FDA Registration Numbers#
- 2028492
- 9615060
Source Documents#
510(k) summary PDF not indicated by FDA
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|---|---|---|---|
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| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | 2014-03-20 |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Ventana Medical Systems, Inc. | 2013-11-22 |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2013-09-26 |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | 2013-09-19 |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | Ventana Medical Systems, Inc. | 2012-04-19 |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | Ventana Medical Systems, Inc. | 2012-03-05 |
| K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | Bioimagene, Inc. | 2010-10-27 |
| K073677 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2008-08-01 |
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | Tripath Imaging | 2007-01-10 |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | Tripath Imaging, Inc. | 2006-09-29 |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | Tripath Imaging, Inc. | 2006-04-11 |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | Tripath Imaging, Inc. | 2005-05-06 |
| K031363 | QCA (VERSION 3.1) | Cell Analysis, Inc. | 2004-02-05 |
Legacy Summary#
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FDA Review#
Decision Summary