The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for In Space 3d.
| Device ID | K011447 |
| 510k Number | K011447 |
| Device Name: | IN SPACE 3D |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Praveen Nadkarni |
| Correspondent | Praveen Nadkarni SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-11 |
| Decision Date | 2001-08-03 |
| Summary: | summary |