The following data is part of a premarket notification filed by Philips Medical Systems Nederland, B.v. with the FDA for Precise Image.
| Device ID | K210760 |
| 510k Number | K210760 |
| Device Name: | Precise Image |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems Nederland, B.V. Veenpluis 4-6 Best Noord-brabant, NL 5684 Pc |
| Contact | Michael Chilbert |
| Correspondent | Michael Chilbert Philips Medical Systems Nederland, B.V. Veenpluis 4-6 Best Noord-brabant, NL 5684 Pc |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2022-01-14 |