Table 5.
FDA cleared digital pathology devices within the last 10 years.
| 510 (k) number* | Product | Product code** | Approval date (mm/dd/yyyy) |
|---|---|---|---|
| K111543 | VIRTUOSO (TM) System for IHC HER2 (4B5) | OEO; NOT | 10/12/2011 |
| K111755 | VIRTUOSO System for IHC KI-67 (30-9) | OEO; NQN; NOT | 02/22/2012 |
| K111869 | VIRTUOSO System for IHC PR (IE2) | OEO; NQN | 03/05/2012 |
| K111872 | VIRTUOSO System for IHC P53 (DO-7) | OEO; NQN; NOT | 04/19/2012 |
| K111914 | Virtual Slide System Olympus VS800 System | OEO | 08/21/2012 |
| K121033 | VIRTUOSO System for IHC KI-67 (30-9) | OEO; NQN; NOT | 09/6/2013 |
| K121350 | VIRTUOSO System for IHC (DO-7) | OEO; NQN; NOT | 06/01/2012 |
| K121516 | VIRTUOSO System for IHC HER2 (4B5) | OEO; NQN; NOT | 09/26/2013 |
| K122143 | VIRTUOSO System for IHC PR (1E2) Benchmark Ultra Stainer | OEO; NQN; NOT | 09/19/2013 |
| K130021 | Philips Herceptest Digital Score | OEO | 09/19/2013 |
| K130515 | VIRTUOSO System for IHC ER (SPI) | OEO; NQN; NOT | 11/22/2013 |
| K131140 | Omnyx IDP for HER2 Manual Application | OEO | 04/01/2014 |
| K140465 | VIRTUOSO System for IHC ER (SP1) with Benchmark Ultra Stainer | OEO; NQN; NOT | 03/20/2014 |
| K140957 | Genasis HIPATH IHC Family | NQN; NOT | 01/15/2015 |
| K141109 | Aperio EPATHOLOGY EIHC IVD System | NQN; NOT | 07/29/2014 |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | OEO | 70/16/2015 |
| K172174 | Philips IntelliSite Pathology Solution | PSY | 10/04/2017 |
| K172922 | Barco N.V. MMPC-4127F1 (PP27QHD) | PZZ | 12/21/2017 |
| K190332 | Aperio AT2 DX System | PSY | 05/20/2019 |
| K192259 | Philips IntelliSite Pathology Solution | PSY | 09/20/2019 |
| K193054 | Sectra Digital Pathology Module | QKQ | 03/31/2020 |
| K201005 | FullFocus | PSY; QKQ | 07/15/2020 |
*
The information listed in this table was collected through searches of FDA's 510 (k) database.
**
The list is limited to the 6 product codes listed in Table 4.