# Konica Minolta Healthcare Americas, Inc.

- Location (FDA's records): Garner, NC
- FDA decisions: 6 (2020–2026): 6 510(k) clearances
- Product codes: KPR (3), MQB (2), LLZ (1)
- 510(k) review time since 2016: median 42 days, against 46 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 3 (3 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
- Viztek, LLC: 2 (https://510kreport.com/company/viztek)
- Radmedix, LLC: 1 (https://510kreport.com/company/radmedix)

## Its most-cited devices
- K193225: KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography (2020), cited by 1
- K214030: Universal DR 1748 (2022), cited by 1
- K214012: Straight Arm DDR (2022), cited by 1

## Recent decisions
- K252996: Universal 1417PI (Jun 12, 2026)
- K221853: Otc DDR (Jul 27, 2022)
- K214030: Universal DR 1748 (Jan 21, 2022)
- K214012: Straight Arm DDR (Jan 12, 2022)
- K203743: EXA (Dec 10, 2021)
- K193225: KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography (Jan 15, 2020)

Source page: https://510kreport.com/company/konica-minolta-healthcare-americas