The following data is part of a premarket notification filed by Deep01 Limited with the FDA for Deepct.
| Device ID | K182875 |
| 510k Number | K182875 |
| Device Name: | DeepCT |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Deep01 Limited Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. Taipei City, TW 10091 |
| Contact | William Lai |
| Correspondent | William Lai Deep01 Limited Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. Taipei City, TW 10091 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-12 |
| Decision Date | 2019-07-10 |