# Infinitt Healthcare Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 4 (2017–2025): 4 510(k) clearances
- Product codes: LLZ (3), QKQ (1)
- 510(k) review time since 2016: median 95 days, against 115 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Infinitt Co., Ltd.: 2 (https://510kreport.com/company/infinitt)
- Hamamatsu Photonics K.K.: 1 (https://510kreport.com/company/hamamatsu-photonics)
- Proknow, LLC: 1 (https://510kreport.com/company/proknow)

## Firms that cite its devices most
- Inviz Corporation: 1 (https://510kreport.com/company/inviz)
- Mediimg Corporation: 1 (https://510kreport.com/company/mediimg)
- Tae Young Soft Co., Ltd.: 1 (https://510kreport.com/company/tae-young-soft)

## Its most-cited devices
- K172803: Infinitt PACS 7.0 (2017), cited by 3

## Recent decisions
- K243449: Infinitt DPS (Dec 9, 2025)
- K193369: Xelis Dental 2.0 (Apr 14, 2020)
- K193498: Infinitt RT PACS (Feb 13, 2020)
- K172803: Infinitt PACS 7.0 (Oct 27, 2017)

Source page: https://510kreport.com/company/infinitt-healthcare