Aloka UST-5280-5
FDA 510(k) K002784 · Aloka Co., Ltd.
510(k) numberK002784
Submission
- Device name
- Aloka UST-5280-5
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- September 6, 2000
- Decision date
- September 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
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| K093488 | Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemIYO · Traditional | 11/20/2009SE |
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| K081843 | Ultrasound Data Analysis System, Model DAS-RS1LLZ · Traditional | 07/15/2008SE |
| K080176 | Aloka Prosound 6 Diagnostic Ultrasound SystemIYN · Traditional | 02/29/2008SE |
| K072285 | Aloka Ssd-Alpha 7 Ultrasound SystemITX · Traditional | 08/30/2007SE |
| K060059 | Aloka SD-3500 Ultrasound SystemIYN · Traditional | 01/13/2006SE |
| K043196 | Aloka Ssd-Alpha 10 Ultrasound SystemIYN · Traditional | 11/30/2004SE |
| K040719 | Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryIYO · Traditional | 03/26/2004SE |
Questions and answers
When was Aloka UST-5280-5 cleared by the FDA?
Aloka UST-5280-5 (K002784) received a 510(k) decision of Substantially Equivalent on September 20, 2000, 14 days after the submission was received.
What is the product code of K002784?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.