Bandview System
FDA 510(k) K012103 · Applied Spectral Imaging , Ltd.
510(k) numberK012103
Submission
- Device name
- Bandview System
- Applicant
- Applied Spectral Imaging , Ltd.
Ra'Ananna 43373, IL - Received
- July 5, 2001
- Decision date
- September 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LNJ – Analyzer, Chromosome, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5260
- Specialty
- Hematology
Other 510(k)s with product code LNJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050236 | FishviewLNJ · Traditional | Applied Spectral Imaging , Ltd. | 06/27/2005SE |
| K940240 | IkarosLNJ · Traditional | Metasystems GmbH | 02/24/1995SE |
| K912085 | Aclaims-IsLNJ · Traditional | W-Technology | 10/31/1991SE |
| K902311 | Genevision - Computer Assisted Chromosome Karyo.LNJ · Traditional | Applied Imaging Corp. | 08/20/1990SE |
| K895095 | Aks IILNJ · Traditional | Amoco Technology Co. | 02/09/1990SE |
| K872755 | Karyotec 100LNJ · Traditional | Amcor Electronics, Ltd. | 09/01/1987SE |
| K864955 | CytoscanLNJ · Traditional | Image Recognition Systems , Ltd. | 03/16/1987SE |
| K861974 | Perceptive Systems Inc Psicom 217 Karyotyping SystLNJ · Traditional | Perceptive Systems, Inc. | 08/04/1986SE |
| K851508 | Nikon/Joyce Lock Magican 2 Chromosome SysLNJ · Traditional | Nikon, Inc. | 07/12/1985SE |
| K851174 | MetachromeLNJ · Traditional | Potomac Medical System | 05/23/1985SE |
More from Potomac Medical System
| 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 |
| 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 |
| K973950 | Retinal CubeHKI · Traditional | 12/12/1997SE |
Questions and answers
When was Bandview System cleared by the FDA?
Bandview System (K012103) received a 510(k) decision of Substantially Equivalent on September 14, 2001, 71 days after the submission was received.
What is the product code of K012103?
The FDA product code is LNJ – Analyzer, Chromosome, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5260.