510(k) K050236
- Device
- FISHVIEW
- Applicant
- APPLIED SPECTRAL IMAGING, LTD.
- 510(k) number
- K050236
- Product code
- LNJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-27
- Date received
- 2005-01-31
- Regulation
- 864.5260
- Classification name
- Analyzer, Chromosome, Automated
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAN LAOR
- Address
- 6 Sireni St. Haifa IL 32972 32972
FDA Registration Numbers#
- 9615060
- 9680625
Source Documents#
Other 510(k) Records For Product Code LNJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K012103 | BANDVIEW SYSTEM | Applied Spectral Imaging , Ltd. | 2001-09-14 |
| K940240 | IKAROS | Metasystems GmbH | 1995-02-24 |
| K912085 | ACLAIMS-IS | W-Technology | 1991-10-31 |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Applied Imaging Corp. | 1990-08-20 |
| K895095 | AKS II | Amoco Technology Co. | 1990-02-09 |
| K872755 | KARYOTEC 100 | Amcor Electronics, Ltd. | 1987-09-01 |
| K864955 | CYTOSCAN | Image Recognition Systems , Ltd. | 1987-03-16 |
| K861974 | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST | Perceptive Systems, Inc. | 1986-08-04 |
| K851508 | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS | Nikon, Inc. | 1985-07-12 |
| K851174 | METACHROME | Potomac Medical System | 1985-05-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary