The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Oldelft Thorascan Model Number 180t.
| Device ID | K012165 |
| 510k Number | K012165 |
| Device Name: | OLDELFT THORASCAN MODEL NUMBER 180T |
| Classification | System, X-ray, Stationary |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Lisa Dimmick |
| Correspondent | Lisa Dimmick NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-09-19 |
| Summary: | summary |