The following data is part of a premarket notification filed by Kontron Medical Systems Sas with the FDA for Sigma 5000 Series Imagic Ultrasound System.
| Device ID | K053084 |
| 510k Number | K053084 |
| Device Name: | SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | KONTRON MEDICAL SYSTEMS SAS 17725 N.E. 65TH STREET BLDG. C Redmond, WA 98052 -4911 |
| Contact | Larry Walker |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2005-11-16 |
| Summary: | summary |