Modification to: EUB-6500 Diagnostic Ultrasound Scanner
FDA 510(k) K013723 · Hitachi Medical Corp.
510(k) numberK013723
Submission
- Device name
- Modification to: EUB-6500 Diagnostic Ultrasound Scanner
- Applicant
- Hitachi Medical Corp.
Tarrytown, NY, US - Received
- November 9, 2001
- Decision date
- February 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
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| K160559 | NOBLUS Ultrasound Diagnostic SystemIYN · Traditional | 10/18/2016SE |
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| K061608 | Modification to EUB-5500 Diagnostic Ultrasound ScannerIYN · Special | 11/22/2006SE |
| K053258 | EUB-6500 Diagnostic Ultrasound ScannerIYN · Special | 12/09/2005SE |
| K042501 | ETG-4000 Optical Topography SystemDQA · Special | 10/12/2004SE |
| K013722 | Modification to: EUB-8500 Diagnostic Ultrasound ScannerIYN · Special | 02/11/2002SE |
| K012239 | Modifications to EUB-525 Diagnostic Ultrasound Scanner; EUB-2000 Diagnostic Ultrasound…IYN · Traditional | 08/10/2001SE |
| K011252 | EUB-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe SystemIYO · Traditional | 05/30/2001SE |
| K926209 | EUB-555IYO · Traditional | 06/03/1994SE |
| K910268 | Transducers, EUP-C318/V33/F334/CC331/B31/032TITX · Traditional | 04/15/1991SE |
Questions and answers
When was Modification to: EUB-6500 Diagnostic Ultrasound Scanner cleared by the FDA?
Modification to: EUB-6500 Diagnostic Ultrasound Scanner (K013723) received a 510(k) decision of Substantially Equivalent on February 6, 2002, 89 days after the submission was received.
What is the product code of K013723?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.