The following data is part of a premarket notification filed by Philips Medical Systems, Nederland B.v. with the FDA for Smartct R1.0.
| Device ID | K201583 |
| 510k Number | K201583 |
| Device Name: | SmartCT R1.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Maria Silos Viu |
| Correspondent | Maria Silos Viu Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| Subsequent Product Code | JAK |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2021-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085732 | K201583 | 000 |