The following data is part of a premarket notification filed by Medicsight with the FDA for Mediclung, Release 1.
| Device ID | K033412 |
| 510k Number | K033412 |
| Device Name: | MEDICLUNG, RELEASE 1 |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | MEDICSIGHT 46 BERKELEY SQUARE London, GB W 1j 5at |
| Contact | Carol Macdonald |
| Correspondent | Carol Macdonald MEDICSIGHT 46 BERKELEY SQUARE London, GB W 1j 5at |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-27 |
| Decision Date | 2003-12-30 |
| Summary: | summary |