The following data is part of a premarket notification filed by Ddd-diagnostic A/s with the FDA for Scintillation Gamma Camera.
| Device ID | K140206 |
| 510k Number | K140206 |
| Device Name: | SCINTILLATION GAMMA CAMERA |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DDD-DIAGNOSTIC A/S 2970 HORSHOLM Denmark, DK Denmark |
| Contact | Neergaards Vej 5e |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05711665003019 | K140206 | 000 |
| 05711665003003 | K140206 | 000 |
| 05711665003002 | K140206 | 000 |