The following data is part of a premarket notification filed by Image Recognition Systems Ltd. with the FDA for Cytoscan.
| Device ID | K864955 |
| 510k Number | K864955 |
| Device Name: | CYTOSCAN |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | IMAGE RECOGNITION SYSTEMS LTD. 720 BIRCHWOOD BLVD., BIRCHWOOD Warrington, Cheshire, GB Wa3 7px |
| Contact | John T Stopford |
| Correspondent | John T Stopford IMAGE RECOGNITION SYSTEMS LTD. 720 BIRCHWOOD BLVD., BIRCHWOOD Warrington, Cheshire, GB Wa3 7px |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-18 |
| Decision Date | 1987-03-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CYTOSCAN 85979893 4411259 Live/Registered |
Affymetrix, Inc. 2012-06-15 |
![]() CYTOSCAN 85653118 4610235 Live/Registered |
Affymetrix, Inc. 2012-06-15 |
![]() CYTOSCAN 85107371 4050437 Live/Registered |
Affymetrix, Inc. 2010-08-13 |
![]() CYTOSCAN 75981253 2543510 Dead/Cancelled |
Cytometrics, Inc. 1999-01-05 |
![]() CYTOSCAN 75615777 not registered Dead/Abandoned |
Cytometrics, Inc. 1999-01-05 |
![]() CYTOSCAN 73794108 not registered Dead/Abandoned |
ISRAEL AIRCRAFT INDUSTRIES LTD. 1989-04-18 |
![]() CYTOSCAN 73683944 1486831 Dead/Cancelled |
SHANDON SOUTHERN PRODUCTS LIMITED 1987-09-14 |