The following data is part of a premarket notification filed by Dynamic Imaging Ltd. with the FDA for Diasus.
| Device ID | K013142 |
| 510k Number | K013142 |
| Device Name: | DIASUS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DYNAMIC IMAGING LTD. 9 COCHRANE SQUARE, BRUCEFIELD INDUSTRIAL PARK Livingston, GB Eh54 9dr |
| Contact | Allen Findlay |
| Correspondent | R. Kent Donohue UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-09-20 |
| Decision Date | 2001-10-05 |
| Summary: | summary |