Acis (Automated Cellular Imaging System)
FDA 510(k) K032113 · Chroma Vision Medical Systems, Inc.
510(k) numberK032113
Submission
- Device name
- Acis (Automated Cellular Imaging System)
- Applicant
- Chroma Vision Medical Systems, Inc.
San Juan Capistrano, CA, US - Received
- July 9, 2003
- Decision date
- December 23, 2003
- 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.
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| 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 |
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Questions and answers
When was Acis (Automated Cellular Imaging System) cleared by the FDA?
Acis (Automated Cellular Imaging System) (K032113) received a 510(k) decision of Substantially Equivalent on December 23, 2003, 167 days after the submission was received.
What is the product code of K032113?
The FDA product code is NOT – Microscope, Automated, Image Analysis, Operator Intervention, a Class II (moderate risk) device regulated under 21 CFR 864.1860.