Genasis Hipath Ihc Family
FDA 510(k) K140957 · Applied Spectral Imaging , Ltd.
510(k) numberK140957
Submission
- Device name
- Genasis Hipath Ihc Family
- Applicant
- Applied Spectral Imaging , Ltd.
Caesarea, IL - Received
- April 14, 2014
- Decision date
- January 15, 2015
- 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 |
|---|---|---|---|
| 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 |
| K121516 | Virtuoso System for Ihc HER2 (4B5)NQN · Traditional | Ventana Medical Systems, Inc. | 09/26/2013SE |
| 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 |
|---|---|---|
| K122554 | Genasis Scanview SystemNTH · Traditional | 02/07/2013SE |
| K110345 | Scanview SystemNTH · Traditional | 10/19/2011SE |
| K101291 | Scanview HER2/NEU Fish SystemNTH · Traditional | 11/23/2010SE |
| K071398 | Scanview, Model SC-300JOY · Traditional | 10/04/2007SE |
| K050236 | FishviewLNJ · Traditional | 06/27/2005SE |
| K012103 | Bandview SystemLNJ · Traditional | 09/14/2001SE |
| K973950 | Retinal CubeHKI · Traditional | 12/12/1997SE |
Questions and answers
When was Genasis Hipath Ihc Family cleared by the FDA?
Genasis Hipath Ihc Family (K140957) received a 510(k) decision of Substantially Equivalent on January 15, 2015, 276 days after the submission was received.
What is the product code of K140957?
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.