# Radisen Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 3 (2018–2022): 3 510(k) clearances
- Names in FDA's records: Radisen Co., Ltd. (2); Radisen, Inc. (1)
- Product codes: MQB (2), LLZ (1)
- 510(k) review time since 2016: median 58 days, against 48 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Jpi Healthcare Solutions, Inc.: 1 (https://510kreport.com/company/jpi-healthcare-solutions)

## Its most-cited devices
- K180989: PEDRA-17F Digital Flat Panel X-ray Detector (2018), cited by 1

## Recent decisions
- K213520: Axir-CX (Aug 19, 2022)
- K221144: Pedra-1417MC, Pedra-1417MG, Pedra-1417FC, Pedra-1417FG (May 13, 2022)
- K180989: PEDRA-17F Digital Flat Panel X-ray Detector (Jun 13, 2018)

Source page: https://510kreport.com/company/radisen