Analyzer, Chromosome, Automated
Analyzer, Chromosome, Automated is an automated image analysis system used in cytogenetics laboratories to capture, classify, and analyze chromosomal spreads (karyotypes) obtained from cultured cells, facilitating the detection of chromosomal abnormalities associated with genetic disorders, cancers, and prenatal conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNJ, regulated under 21 CFR 864.5260, within the Hematology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LNJ
- Device Class
- FDA class 2
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050236 | FISHVIEW | Jun 27, 2005 | Substantially Equivalent | Applied Spectral Imaging , Ltd. |
| K012103 | BANDVIEW SYSTEM | Sep 14, 2001 | Substantially Equivalent | Applied Spectral Imaging , Ltd. |
| K940240 | IKAROS | Feb 24, 1995 | Substantially Equivalent | Metasystems GmbH |
| K912085 | ACLAIMS-IS | Oct 31, 1991 | Substantially Equivalent | W-Technology |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Aug 20, 1990 | Substantially Equivalent | Applied Imaging Corp. |
| K895095 | AKS II | Feb 09, 1990 | Substantially Equivalent | Amoco Technology Co. |
| K872755 | KARYOTEC 100 | Sep 01, 1987 | Substantially Equivalent | Amcor Electronics, Ltd. |
| K864955 | CYTOSCAN | Mar 16, 1987 | Substantially Equivalent | Image Recognition Systems , Ltd. |
| K861974 | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST | Aug 04, 1986 | Substantially Equivalent | Perceptive Systems, Inc. |
| K851508 | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS | Jul 12, 1985 | Substantially Equivalent | Nikon, Inc. |
| K851174 | METACHROME | May 23, 1985 | Substantially Equivalent | Potomac Medical System |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.