Aloka Co., Ltd.
Wallingford, CT, US
Aloka Co., Ltd. appears in FDA device records in Wallingford, CT. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Aloka Co., Ltd. between 1992 and 2011. The busiest year on record is 2001, with 5. The most recent is 2011, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 1 |
| 2011 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111227 | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K110207 | ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K093488 | ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K083254 | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K081843 | ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 | LLZ | Substantially Equivalent | |
| K080176 | ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K060059 | ALOKA SD-3500 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K043196 | ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | IYO | Substantially Equivalent | |
| K033311 | ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K023996 | ALOKA SSD-3500 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K020668 | ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 | IYO | Substantially Equivalent | |
| K012253 | SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K012080 | SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K011457 | ALOKA SSD-5500 WITH KI AND A-SMA | IYN | Substantially Equivalent | |
| K011315 | SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 | IYN | Substantially Equivalent | |
| K011314 | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K003739 | ALOKA SSD-4000 | IYN | Substantially Equivalent | |
| K002784 | ALOKA UST-5280-5 | ITX | Substantially Equivalent | |
| K992663 | ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K983879 | ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K974544 | ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | |
| K972465 | ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K964549 | ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | |
| K963616 | ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K954022 | ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K950607 | UST-5268P-5 TRANSDUCER | KRK | Substantially Equivalent | |
| K943113 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K943637 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K941652 | ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION | IYN | Substantially Equivalent | |
| K925646 | SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS. | IYO | Substantially Equivalent | |
| K925486 | UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS. | ITX | Substantially Equivalent | |
| K923269 | CONVEX AND LINEAR ARRAY TRANSDUCERS | IYO | Substantially Equivalent | |
| K922549 | UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 | ITX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Aloka Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Aloka Co., Ltd.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain