Leica Biosystems Imaging, Inc.
Vista, CA, US
Leica Biosystems Imaging, Inc. appears in FDA device records in Vista, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Leica Biosystems Imaging, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Aperio Technologies510(k), enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Leica Biosystems Imaging, Inc. between 2007 and 2026. The busiest year on record is 2007, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253561 | Aperio iQC DX Software | QKQ | Substantially Equivalent | |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | PSY | Substantially Equivalent | |
| K232202 | Aperio GT 450 DX | PSY | Substantially Equivalent | |
| K190332 | Aperio AT2 DX System | PSY | Substantially Equivalent | |
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | NOT | Substantially Equivalent | |
| K080564 | SCANSCOPE XT SYSTEM | NOT | Substantially Equivalent | |
| K080254 | SCANSCOPE XT SYSTEM | OEO | Substantially Equivalent | |
| K073677 | SCANSCOPE XT SYSTEM | NQN | Substantially Equivalent | |
| K071671 | SCANSCOPE XT SYSTEM | OEO | Substantially Equivalent | |
| K071128 | SCANSCOPE XT SYSTEM | NOT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006791373 | 3006791373 | Leica Biosystems Imaging, Inc. | 1360 Park Center Drive, Vista, CA 92081 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OEOAutomated Digital Image Manual Interpretation Microscope
- QKQDigital Pathology Image Viewing And Management Software
- NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- NOTMicroscope, Automated, Image Analysis, Operator Intervention
- PSYWhole Slide Imaging System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0046-2020 | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. | The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images. | Class II | Terminated | |
| Z-1152-2014 | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest", it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin clinical outcome has not been established. Manual Read of HER2 Digital Slides: The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin clinical outcome has not been established. ER/PR Image Analysis: The ScanScope XT System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo | In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i | Class II | Terminated | |
| Z-1549-2013 | Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides. | Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain