The following data is part of a premarket notification filed by Ddd-diagnostic A/s with the FDA for Quantumcam.
| Device ID | K161674 |
| 510k Number | K161674 |
| Device Name: | QuantumCam |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DDD-DIAGNOSTIC A/S DR. NEERGAARDS VEJ 5E Horsholm, DK 2970 |
| Contact | Niels Sorensen |
| Correspondent | Niels Sorensen DDD-DIAGNOSTIC A/S DR. NEERGAARDS VEJ 5E Horsholm, DK 2970 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-16 |
| Decision Date | 2016-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05711665003033 | K161674 | 000 |