The following data is part of a premarket notification filed by Blue X Imaging Srl with the FDA for Pantos, Models: Pantos 16, And Pantos Dg.
| Device ID | K031801 |
| 510k Number | K031801 |
| Device Name: | PANTOS, MODELS: PANTOS 16, AND PANTOS DG |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| Subsequent Product Code | EHD |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-11 |
| Decision Date | 2003-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E31584682012000 | K031801 | 000 |
| E31584682005000 | K031801 | 000 |
| E31584682003000 | K031801 | 000 |
| E31584682001000 | K031801 | 000 |