# Radmedix, LLC

- Location (FDA's records): Dayton, OH
- FDA decisions: 6 (2020–2023): 6 510(k) clearances
- Product codes: MQB (3), KPR (2), IZL (1)
- 510(k) review time since 2016: median 30 days, against 41 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 7 (4 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
- Minxray, Inc.: 1 (https://510kreport.com/company/minxray)
- Visaris D.O.O. Belgrade: 1 (https://510kreport.com/company/visaris-doo-belgrade)

## Firms that cite its devices most
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui): 2 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instruments-co-siui)
- Konica Minolta Healthcare Americas, Inc.: 1 (https://510kreport.com/company/konica-minolta-healthcare-americas)

## Its most-cited devices
- K200726: AcuityPDR (2020), cited by 3
- K210919: AcuityDRe (2021), cited by 2
- K201058: Accuvue+ (2020), cited by 1
- K193360: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (2020), cited by 1

## Recent decisions
- K231995: AcuityUDR (Oct 25, 2023)
- K231709: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 (Jul 12, 2023)
- K210919: AcuityDRe (Apr 30, 2021)
- K201058: Accuvue+ (May 6, 2020)
- K200726: AcuityPDR (Apr 13, 2020)
- K193360: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (Jan 2, 2020)

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