The following data is part of a premarket notification filed by Sedecal, Sa. with the FDA for Radiographic System Challenge X.
| Device ID | K202293 |
| 510k Number | K202293 |
| Device Name: | Radiographic System Challenge X |
| Classification | System, X-ray, Stationary |
| Applicant | Sedecal, SA. C/ Pelaya, 9 -13 Pol. Ind. Rio De Janeiro Algete, ES 28110 |
| Contact | Mª Luisa Gómez De Agüero |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-13 |
| Decision Date | 2020-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436046002388 | K202293 | 000 |