Sonoace 600 Diagnostic Ultrasound System
FDA 510(k) K000030 · Medison America, Inc.
510(k) numberK000030
Submission
- Device name
- Sonoace 600 Diagnostic Ultrasound System
- Applicant
- Medison America, Inc.
Pleasanton, CA, US - Received
- January 5, 2000
- Decision date
- January 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K993517 | Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) OptionIYO · Traditional | 11/02/1999SE |
| K992761 | Sonoace 5500 Diagnostic Ultrasound SystemIYO · Traditional | 09/01/1999SE |
Questions and answers
When was Sonoace 600 Diagnostic Ultrasound System cleared by the FDA?
Sonoace 600 Diagnostic Ultrasound System (K000030) received a 510(k) decision of Substantially Equivalent on January 19, 2000, 14 days after the submission was received.
What is the product code of K000030?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.