Virtuoso System for Ihc HER2 (4B5)
FDA 510(k) K121516 · Ventana Medical Systems, Inc.
510(k) numberK121516
Submission
- Device name
- Virtuoso System for Ihc HER2 (4B5)
- Applicant
- Ventana Medical Systems, Inc.
Los Angeles, CA, US - Received
- May 22, 2012
- Decision date
- September 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQN – Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Other 510(k)s with product code NQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140957 | Genasis Hipath Ihc FamilyNQN · Traditional | Applied Spectral Imaging , Ltd. | 01/15/2015SE |
| K140465 | Virtuoso System for Ihc Er (SP1) with Benchmark Ultra StainerNQN · Traditional | Ventana Medical Systems, Inc. | 03/20/2014SE |
| K130515 | Virtuoso System for Ihc Er (Spi)NQN · Traditional | Ventana Medical Systems, Inc. | 11/22/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | Ventana Medical Systems, Inc. | 09/19/2013SE |
| K111872 | Virtuoso System for Ihc P53 (DO-7)NQN · Traditional | Ventana Medical Systems, Inc. | 04/19/2012SE |
| K111869 | Virtuoso System for Ihc PR (IE2)NQN · Traditional | Ventana Medical Systems, Inc. | 03/05/2012SE |
| K092333 | Pathiam System with Iscan for P53 and KI-67NQN · Traditional | Bioimagene, Inc. | 10/27/2010SE |
| K073677 | Scanscope XT SystemNQN · Traditional | Aperio Technologies | 08/01/2008SE |
| K061613 | Ventana Image Analysis System - Pathway HER2 (4B5)NQN · Traditional | Tripath Imaging | 01/10/2007SE |
| K062428 | Ventana Image Analysis System, Model ViasNQN · Traditional | Tripath Imaging, Inc. | 09/29/2006SE |
More from Tripath Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242783 | Roche Digital Pathology DxPSY · Special | 12/17/2024SE |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200)PSY · Traditional | 06/14/2024SE |
| K212176 | CINtec HistologyPRB · Traditional | 12/10/2021SE |
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | 05/08/2018SE |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional | 07/16/2015SE |
| K140465 | Virtuoso System for Ihc Er (SP1) with Benchmark Ultra StainerNQN · Traditional | 03/20/2014SE |
| K130515 | Virtuoso System for Ihc Er (Spi)NQN · Traditional | 11/22/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | 09/19/2013SE |
| K121033 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | 09/06/2013SE |
| K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyMYA · Traditional | 12/17/2012SE |
Questions and answers
When was Virtuoso System for Ihc HER2 (4B5) cleared by the FDA?
Virtuoso System for Ihc HER2 (4B5) (K121516) received a 510(k) decision of Substantially Equivalent on September 26, 2013, 492 days after the submission was received.
What is the product code of K121516?
The FDA product code is NQN – Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity, a Class II (moderate risk) device regulated under 21 CFR 864.1860.