FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONACE 2000
K Number: K923246
·
Decision May 20, 1993
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
24
Review Days
322
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Basic Information
- Device Name
- SONACE 2000
- K Number
- K923246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medison Co., Ltd.
- Date Received
- July 2, 1992
- Decision Date
- May 20, 1993
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Medison Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K103397 | ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM | Feb 25, 2011 | Substantially Equivalent |
| K103722 | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 5, 2011 | Substantially Equivalent |
| K102065 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 6, 2010 | Substantially Equivalent |
| K101455 | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 19, 2010 | Substantially Equivalent |
| K101829 | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 16, 2010 | Substantially Equivalent |
| K100186 | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 24, 2010 | Substantially Equivalent |
| K093849 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 19, 2010 | Substantially Equivalent |
| K093714 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 10, 2009 | Substantially Equivalent |
| K092159 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 28, 2009 | Substantially Equivalent |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 2, 2008 | Substantially Equivalent |