Infinitt RT PACS— 510(k) K193498
Substantially EquivalentInfinitt Healthcare Co., Ltd.
FDA 510(k) clearance K193498 for Infinitt RT PACS, Substantially Equivalent on 2020-02-13. Applicant: Infinitt Healthcare Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Infinitt Healthcare Co., Ltd.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code LLZ
view allMore clearances from Infinitt Healthcare Co., Ltd.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . 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.