The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for Portable Ultrasonic Diagnostic System.
| Device ID | K123616 |
| 510k Number | K123616 |
| Device Name: | PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED P.O. BOX 237-023 Shanghai, CN 237-023 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SONOSCAPE COMPANY LIMITED P.O. BOX 237-023 Shanghai, CN 237-023 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868616014 | K123616 | 000 |
| 06945868600594 | K123616 | 000 |
| 06945868600600 | K123616 | 000 |
| 06945868600617 | K123616 | 000 |
| 06945868600624 | K123616 | 000 |
| 06945868600631 | K123616 | 000 |
| 06945868600648 | K123616 | 000 |
| 06945868601119 | K123616 | 000 |
| 06945868601126 | K123616 | 000 |
| 06945868601133 | K123616 | 000 |
| 06945868601140 | K123616 | 000 |
| 06945868616007 | K123616 | 000 |
| 06945868600587 | K123616 | 000 |