The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc., Ultrasound Di with the FDA for Sequoia Plus Diagnostic Ultrasound System.
| Device ID | K072365 |
| 510k Number | K072365 |
| Device Name: | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Robert Lawrence |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | 2007-08-23 |
| Decision Date | 2007-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005379 | K072365 | 000 |
| 04056869003702 | K072365 | 000 |
| 04056869003696 | K072365 | 000 |
| 04056869003689 | K072365 | 000 |
| 04056869003184 | K072365 | 000 |
| 04056869003160 | K072365 | 000 |
| 04056869003153 | K072365 | 000 |
| 04056869003146 | K072365 | 000 |
| 04056869003122 | K072365 | 000 |
| 04056869003108 | K072365 | 000 |
| 04056869003092 | K072365 | 000 |
| 04056869003078 | K072365 | 000 |
| 04056869003016 | K072365 | 000 |
| 04056869002989 | K072365 | 000 |
| 04056869002972 | K072365 | 000 |
| 04056869002934 | K072365 | 000 |
| 04056869002927 | K072365 | 000 |
| 04056869002910 | K072365 | 000 |
| 04056869005065 | K072365 | 000 |
| 04056869005072 | K072365 | 000 |
| 04056869005089 | K072365 | 000 |
| 04056869005294 | K072365 | 000 |
| 04056869005287 | K072365 | 000 |
| 04056869005256 | K072365 | 000 |
| 04056869005249 | K072365 | 000 |
| 04056869005232 | K072365 | 000 |
| 04056869005225 | K072365 | 000 |
| 04056869005201 | K072365 | 000 |
| 04056869005195 | K072365 | 000 |
| 04056869005171 | K072365 | 000 |
| 04056869005164 | K072365 | 000 |
| 04056869005157 | K072365 | 000 |
| 04056869005140 | K072365 | 000 |
| 04056869005133 | K072365 | 000 |
| 04056869005126 | K072365 | 000 |
| 04056869005119 | K072365 | 000 |
| 04056869005102 | K072365 | 000 |
| 04056869005096 | K072365 | 000 |
| 04056869002866 | K072365 | 000 |