Sonoline SX Ultrasound Scanner
FDA 510(k) K852739 · Siemens Medical Solutions USA, Inc.
510(k) numberK852739
Submission
- Device name
- Sonoline SX Ultrasound Scanner
- Applicant
- Siemens Medical Solutions USA, Inc.
Iselin, NJ, US - Received
- June 27, 1985
- Decision date
- March 10, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
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| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904977 | Cine/View Plus - Cardiology WorkstationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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Questions and answers
When was Sonoline SX Ultrasound Scanner cleared by the FDA?
Sonoline SX Ultrasound Scanner (K852739) received a 510(k) decision of Substantially Equivalent on March 10, 1986, 256 days after the submission was received.
What is the product code of K852739?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.