Data / Medical devices / United Kingdom / Claritas Healthtech Limited
Claritas Healthtech Limited: FDA-registered device maker in London London, City of, United Kingdom, 3 510(k) clearances
Claritas Healthtech Limited is registered with the FDA (registration 3030979155) in London London, City of, United Kingdom. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030979155
- Address
- 120 Regent Street, London London, City of, United Kingdom, W1B 5FE
- Owner or operator
- Claritas HealthTech Limited (10095697)
- Roles
- Manufacturer
- First device listed
- April 15, 2026
- Registered through
- 2026
- Brand names listed
- Claritas iPET, Claritas iRAD, iPETcertum
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2025 | K244016 | iPETcertum (v1.0) | LLZ | Substantially Equivalent | Claritas Healthtech Pte, Ltd. | accessdata.fda.gov |
| December 22, 2021 | K213140 | Claritas iPET | LLZ | Substantially Equivalent | Claritas Healthtech Pte, Ltd. | accessdata.fda.gov |
| October 20, 2021 | K212470 | iRAD | LLZ | Substantially Equivalent | Claritas Healthtech Pte, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.