# Aloka Co., Ltd.

- Location (FDA's records): Wallingford, CT
- FDA decisions: 39 (1982–2011): 39 510(k) clearances
- Product codes: IYN (17), ITX (8), IYO (8), KRK (1), LLZ (1)
- Predicates its devices cite: 25 (21 its own); citations of its devices by later devices: 52 (21 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aloka Co. Ltd USA: 2 (https://510kreport.com/company/aloka-co-usa)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Advanced Technology Laboratories, Inc.: 1 (https://510kreport.com/company/advanced-technology-laboratories)

## Firms that cite its devices most
- Aloka Co. Ltd USA: 5 (https://510kreport.com/company/aloka-co-usa)
- Olympus Medical Systems Corp.: 5 (https://510kreport.com/company/olympus-medical-systems)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 4 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Perception, Inc.: 4 (https://510kreport.com/company/perception)
- Esaote, S.p.A.: 3 (https://510kreport.com/company/esaote)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical: 2 (https://510kreport.com/company/hitachi-aloka-medical-hitachi-aloka-medical)
- Hitachi Aloka Medical, Ltd.: 2 (https://510kreport.com/company/hitachi-aloka-medical)
- Biosound, Inc.: 1 (https://510kreport.com/company/biosound)

## Its most-cited devices
- K963616: Aloka SSD-1700 Diagnostic Ultrasound System (1997), cited by 5
- K992663: Aloka SSD-5500 Diagnostic Ultrasound System (1999), cited by 5
- K012080: SSD-5000 Diagnostic Ultrasound System (2001), cited by 4
- K011314: Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System (2001), cited by 4
- K043196: Aloka SSD-Alpha 10 Ultrasound System (2004), cited by 4
- K011315: SSD 5500 with Olympus GF Type UC140P-AL5 (2001), cited by 3

## Recent decisions
- K111227: Aloka SSD-3500 Diagnostic Ultrasound System (May 13, 2011)
- K110207: Aloka Prousound F75 Diagnostic Ultrasound System (Feb 17, 2011)
- K093488: Aloka Prosound Alpha 6 Diagnostic Ultrasound System (Nov 20, 2009)
- K083254: Aloka Prousound 2 Diagnostic Ultrasound System (Dec 19, 2008)
- K081843: Ultrasound Data Analysis System, Model Das-RS1 (Jul 15, 2008)
- K080176: Aloka Prosound 6 Diagnostic Ultrasound System (Feb 29, 2008)
- K072285: Aloka SSD-Alpha 7 Ultrasound System (Aug 30, 2007)
- K060059: Aloka SD-3500 Ultrasound System (Jan 13, 2006)

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