The following data is part of a premarket notification filed by Ivu Imaging Corporation with the FDA for Sofia Automated Tomographic Ultrasound (atus).
| Device ID | K080555 |
| 510k Number | K080555 |
| Device Name: | SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | IVU IMAGING CORPORATION 4121 GRACE LANE Grapevine, TX 76051 |
| Contact | Mark L Stribling |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863522000008 | K080555 | 000 |