The following data is part of a premarket notification filed by Sea Ridge Software, Inc. with the FDA for Imorgon Ultrasound Pacs Solutions.
| Device ID | K050736 |
| 510k Number | K050736 |
| Device Name: | IMORGON ULTRASOUND PACS SOLUTIONS |
| Classification | System, Image Processing, Radiological |
| Applicant | SEA RIDGE SOFTWARE, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook SEA RIDGE SOFTWARE, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863670000349 | K050736 | 000 |
| 00863670000332 | K050736 | 000 |
| 00863670000325 | K050736 | 000 |
| 00863670000318 | K050736 | 000 |
| 00863670000301 | K050736 | 000 |