Virtuoso System for Ihc KI-67 (30-9)
FDA 510(k) K121033 · Ventana Medical Systems, Inc.
510(k) numberK121033
Submission
- Device name
- Virtuoso System for Ihc KI-67 (30-9)
- Applicant
- Ventana Medical Systems, Inc.
Los Angeles, CA, US - Received
- April 5, 2012
- Decision date
- September 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NOT – Microscope, Automated, Image Analysis, Operator Intervention
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Other 510(k)s with product code NOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260755 | OptraSCAN SystemNOT · Traditional | Optrascan, Inc. | 07/02/2026SE |
| K141109 | Aperio Epathology Eihc IVD SystemNOT · Traditional | Leica Biosystems Imaging, Inc. | 07/29/2014SE |
| K121350 | Virtuso System for Ihc (DO-7)NOT · Traditional | Ventana Medical Systems, Inc. | 06/01/2012SE |
| K111755 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | Ventana Medical Systems, Inc. | 02/22/2012SE |
| K111543 | Virtuoso (TM) System for Ihc HER2 (4B5)NOT · Traditional | Ventana Medical Systems, Inc. | 10/12/2011SE |
| K080564 | Scanscope XT SystemNOT · Traditional | Aperio Technologies | 08/14/2009SE |
| K080910 | Pathiam System for HER2/NEU Immunohistochemistry Reagents & KitsNOT · Traditional | Bioimagene, Inc. | 02/04/2009SE |
| K071128 | Scanscope XT SystemNOT · Traditional | Aperio Technologies | 10/10/2007SE |
| K062756 | Pathiam Imaging Software for HER2/NEUNOT · Traditional | Bioimagene, Inc. | 02/20/2007SE |
| K051282 | Ventana Image Analysis System - HER2/NEUNOT · Traditional | Tripath Imaging, Inc. | 08/16/2005SE |
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 |
| K121516 | Virtuoso System for Ihc HER2 (4B5)NQN · Traditional | 09/26/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | 09/19/2013SE |
| K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyMYA · Traditional | 12/17/2012SE |
Questions and answers
When was Virtuoso System for Ihc KI-67 (30-9) cleared by the FDA?
Virtuoso System for Ihc KI-67 (30-9) (K121033) received a 510(k) decision of Substantially Equivalent on September 6, 2013, 519 days after the submission was received.
What is the product code of K121033?
The FDA product code is NOT – Microscope, Automated, Image Analysis, Operator Intervention, a Class II (moderate risk) device regulated under 21 CFR 864.1860.