# Shimadzu Medical Systems

- Location (FDA's records): Gardena, CA
- FDA decisions: 91 (1989–2021): 91 510(k) clearances
- Names in FDA's records: Shimadzu Medical Systems (90); Shimadzu Corporation Medical Systems (1)
- Product codes: JAK (14), JAA (10), IZO (10), IZI (8), LNH (7), IXR (7), IYO (5), IYN (5), ITX (4), ITY (4), IYB (4), IZZ (3)
- Predicates its devices cite: 15 (11 its own); citations of its devices by later devices: 24 (11 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shimadzu Corp.: 3 (https://510kreport.com/company/shimadzu)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)

## Firms that cite its devices most
- Shimadzu Corp.: 10 (https://510kreport.com/company/shimadzu)
- Ge Oec Medical Systems, Inc.: 2 (https://510kreport.com/company/ge-oec-medical-systems)
- Shimadzu Corporation Medical Systems Division: 1 (https://510kreport.com/company/shimadzu-medical-systems-division)

## Its most-cited devices
- K955395: DAR-2400-15B/30B (1995), cited by 4
- K955255: Shimadzu Whole Body X-Ray CT Scanner SCT-7000TX (1996), cited by 4
- K003514: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200 (2001), cited by 2
- K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100 (2005), cited by 2
- K943545: Ceiling Suspended C-Arm Support MH-100 (1995), cited by 2
- K052500: DAR-8000F (2005), cited by 2

## Recent decisions
- K203535: Trinias (Apr 28, 2021)
- K082224: Diagnostic Ultrasound System Sarano, Echo View, Shimasonic (Dec 15, 2008)
- K071289: Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO (Jan 9, 2008)
- K071291: Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1100 (Jan 9, 2008)
- K071287: Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200PRO (Jan 9, 2008)
- K061643: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO (Jul 27, 2006)
- K061637: Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200PRO (Jul 25, 2006)
- K061641: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sarano (Jul 14, 2006)

Source page: https://510kreport.com/company/shimadzu-medical-systems