# Shimadzu Corp.

- Location (FDA's records): Torrance, CA
- FDA decisions: 58 (1979–2026): 58 510(k) clearances
- Names in FDA's records: Shimadzu Corp. (49); Shimadzu Corporation (9)
- Product codes: JAA (9), KPR (8), IZI (6), IYO (6), IZL (5), IZO (4), JAK (4), IZX (3), ITX (3), LLZ (2), OWB (2), IZW (2)
- 510(k) review time since 2016: median 132 days, against 84 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 32 (10 its own); citations of its devices by later devices: 22 (10 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shimadzu Medical Systems: 10 (https://510kreport.com/company/shimadzu-medical-systems)
- Fujifilm Medical System U.S.A., Inc.: 8 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Shimadzu Corporation Medical Systems Division: 1 (https://510kreport.com/company/shimadzu-medical-systems-division)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Canon, Inc.: 1 (https://510kreport.com/company/canon)

## Firms that cite its devices most
- Shimadzu Medical Systems: 3 (https://510kreport.com/company/shimadzu-medical-systems)
- Siemens AG Medical Solutions: 1 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Skanray Technologies Limited: 1 (https://510kreport.com/company/skanray-technologies)
- Villa Sistemi Medicali S.P.A.: 1 (https://510kreport.com/company/villa-sistemi-medicali)
- Agfa Corp.: 1 (https://510kreport.com/company/agfa)
- Arcoma AB: 1 (https://510kreport.com/company/arcoma)
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)

## Its most-cited devices
- K190373: SonialVision G4 (2019), cited by 3
- K050925: Digital Radiography System Radspeed Safire (2005), cited by 3
- K152244: RADspeed Pro (2016), cited by 2
- K031771: Shimadzu Collimator R-30H (2003), cited by 2
- K131075: X-Ray TV System Sonial Vision G4 (2014), cited by 1
- K152294: FDR Visionary Suite (2016), cited by 1

## Recent decisions
- K252099: Trinias (Mar 24, 2026)
- K233719: FDR Visionary Suite (Mar 28, 2024)
- K233722: RADspeed Pro (Feb 23, 2024)
- K191877: FLUOROspeed (Aug 5, 2019)
- K190373: SonialVision G4 (Mar 15, 2019)
- K173517: RADspeed fit (Mar 30, 2018)
- K152294: FDR Visionary Suite (Jul 15, 2016)
- K152244: RADspeed Pro (Jun 20, 2016)

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