The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for Sonoscape Ultrasound System And Transducers Model Ssi-8000, 2p1 Phased Array, 5p1 Phased Array Model 2p1, 5p1, 6v1 Micro.
| Device ID | K102642 |
| 510k Number | K102642 |
| Device Name: | SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED 30251 CEDARBROOK ROAD Hayward, CA 94544 |
| Contact | Min Yao |
| Correspondent | Min Yao SONOSCAPE COMPANY LIMITED 30251 CEDARBROOK ROAD Hayward, CA 94544 |
| 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 | No |
| Combination Product | No |
| Date Received | 2010-09-13 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868680015 | K102642 | 000 |
| 06945868600020 | K102642 | 000 |
| 06945868600037 | K102642 | 000 |
| 06945868600044 | K102642 | 000 |
| 06945868600051 | K102642 | 000 |
| 06945868600075 | K102642 | 000 |
| 06945868600099 | K102642 | 000 |
| 06945868600129 | K102642 | 000 |
| 06945868600136 | K102642 | 000 |
| 06945868600143 | K102642 | 000 |
| 06945868600150 | K102642 | 000 |
| 06945868600181 | K102642 | 000 |
| 06945868600204 | K102642 | 000 |
| 06945868680008 | K102642 | 000 |
| 06945868600013 | K102642 | 000 |