The following data is part of a premarket notification filed by Claritas Healthtech Pte Ltd with the FDA for Claritas Ipet.
| Device ID | K213140 |
| 510k Number | K213140 |
| Device Name: | Claritas IPET |
| Classification | System, Image Processing, Radiological |
| Applicant | Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore, SG 088443 |
| Contact | Devika Dutt |
| Correspondent | Devika Dutt Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore, SG 088443 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2021-12-22 |