The following data is part of a premarket notification filed by Blue X Imaging Srl with the FDA for Intraos 70.
| Device ID | K031118 |
| 510k Number | K031118 |
| Device Name: | INTRAOS 70 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | BLUE X IMAGING SRL 251 E. DUNDEE RD. SUITE #6 Wheeling, IL 60090 |
| Contact | Al Sosa |
| Correspondent | Al Sosa BLUE X IMAGING SRL 251 E. DUNDEE RD. SUITE #6 Wheeling, IL 60090 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-08 |
| Decision Date | 2003-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E31593250013000 | K031118 | 000 |
| E31593202013000 | K031118 | 000 |
| E31562802700 | K031118 | 000 |
| 00837699000116 | K031118 | 000 |
| 00837699000093 | K031118 | 000 |
| 00990010301306 | K031118 | 000 |
| 00990010301283 | K031118 | 000 |