The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Integrated Registration.
| Device ID | K093234 |
| 510k Number | K093234 |
| Device Name: | INTEGRATED REGISTRATION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE BP 34 Buc Cedex, FR 78533 |
| Contact | Sophie Le Loarer |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2009-10-30 |
| Summary: | summary |