The following data is part of a premarket notification filed by Bar Code Computer Ltd with the FDA for Dicom Video.
Device ID | K132183 |
510k Number | K132183 |
Device Name: | DICOM VIDEO |
Classification | Digitizer, Image, Radiological |
Applicant | BAR CODE COMPUTER LTD 6 SIRENI Haifa, IL 32972 |
Contact | Dan Laor |
Correspondent | Dan Laor BAR CODE COMPUTER LTD 6 SIRENI Haifa, IL 32972 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-15 |
Decision Date | 2013-10-03 |
Summary: | summary |