Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) Option
FDA 510(k) K993517 · Medison America, Inc.
510(k) numberK993517
Submission
- Device name
- Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) Option
- Applicant
- Medison America, Inc.
Pleasanton, CA, US - Received
- October 18, 1999
- Decision date
- November 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code IYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260190 | ArthurIYO · Traditional | ROPCA ApS | 06/18/2026SE |
| K252237 | EdgeFlow UW20IYO · Traditional | Edgecare, Inc. | 04/17/2026SE |
| K254021 | Accuro XVIYO · Traditional | Rivanna Medical, Inc. | 04/09/2026SE |
| K253898 | QT Scanner 2000 Model AIYO · Special | QT Imaging Holdings, Inc. | 03/04/2026SE |
| K253714 | IntraSight PlusIYO · Traditional | Philips Image Guided Therapy Corporation | 02/24/2026SE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 02/06/2026SE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional | DeepSight Technology, Inc. | 08/01/2025SE |
| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K032329 | SA 9900 Plus Diagnostic Ultrasound SystemIYN · Traditional | 08/06/2003SE |
| K031552 | Mycolor 202 Diagnostic Ultrasound System and TransducersIYN · Traditional | 05/30/2003SE |
| K013627 | Sonoace SA-8000 Diagnostic Ultrasound SystemIYN · Traditional | 11/16/2001SE |
| K012887 | SA6000II Diagnostic Ultrasound SystemIYO · Traditional | 09/12/2001SE |
| K012867 | Sonoace 9900 Diagnostic Ultrasound SystemIYN · Traditional | 09/12/2001SE |
| K003525 | Voluson 730 Diagnostic Ultrasound SystemIYN · Traditional | 11/22/2000SE |
| K003121 | Mysono 201 Diagnostic Ultrasound and TransducersIYO · Traditional | 10/20/2000SE |
| K002185 | Sonoace SA 9900 Diagnostic Ultrasound SystemIYN · Traditional | 08/01/2000SE |
| K000030 | Sonoace 600 Diagnostic Ultrasound SystemIYO · Traditional | 01/19/2000SE |
| K992761 | Sonoace 5500 Diagnostic Ultrasound SystemIYO · Traditional | 09/01/1999SE |
Questions and answers
When was Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) Option cleared by the FDA?
Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) Option (K993517) received a 510(k) decision of Substantially Equivalent on November 2, 1999, 15 days after the submission was received.
What is the product code of K993517?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.