iPETcertum (v1.0)— 510(k) K244016

Name: FDA 510(k) clearance K244016
Creator: U.S. Food and Drug Administration
Published: 2025-08-05

Substantially Equivalent

Claritas Healthtech Pte, Ltd.

FDA 510(k) clearance K244016 for iPETcertum (v1.0), Substantially Equivalent on 2025-08-05. Applicant: Claritas Healthtech Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Claritas Healthtech Pte, Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-12-27
Decision date: 2025-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Claritas Healthtech Pte, Ltd.

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K213140 — Claritas iPET2021-12-22
K212470 — iRAD2021-10-20

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.