Scanview HER2/NEU Fish System
FDA 510(k) K101291 · Applied Spectral Imaging , Ltd.
510(k) numberK101291
Submission
- Device name
- Scanview HER2/NEU Fish System
- Applicant
- Applied Spectral Imaging , Ltd.
Haifa, IL - Received
- May 7, 2010
- Decision date
- November 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTH – System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4700
- Specialty
- Immunology
Other 510(k)s with product code NTH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130775 | Duet SystemNTH · Traditional | Bioview , Ltd. | 05/09/2014SE |
| K122554 | Genasis Scanview SystemNTH · Traditional | Applied Spectral Imaging , Ltd. | 02/07/2013SE |
| K110345 | Scanview SystemNTH · Traditional | Applied Spectral Imaging | 10/19/2011SE |
| K080909 | Iconoscope Oncofish HER2 Test System, Model 2000NTH · Traditional | Ikonisys, Inc. | 10/17/2008SE |
| K043519 | Ariol HER-2/NEU FishNTH · Traditional | Applied Imaging Corp. | 04/25/2005SE |
| K042542 | Cytovision for Cep XyNTH · Traditional | Applied Imaging Corp. | 01/10/2005SE |
More from Applied Imaging Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K140957 | Genasis Hipath Ihc FamilyNQN · Traditional | 01/15/2015SE |
| K122554 | Genasis Scanview SystemNTH · Traditional | 02/07/2013SE |
| K110345 | Scanview SystemNTH · Traditional | 10/19/2011SE |
| 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 Scanview HER2/NEU Fish System cleared by the FDA?
Scanview HER2/NEU Fish System (K101291) received a 510(k) decision of Substantially Equivalent on November 23, 2010, 200 days after the submission was received.
What is the product code of K101291?
The FDA product code is NTH – System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.4700.