FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOACE 6000/ ULTRAMARK 400
K Number: K981510
·
Decision May 8, 1998
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
21
Review Days
10
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Basic Information
- Device Name
- SONOACE 6000/ ULTRAMARK 400
- K Number
- K981510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medison America, Inc.
- Date Received
- April 28, 1998
- Decision Date
- May 8, 1998
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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|---|---|---|---|
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| K003525 | VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 22, 2000 | Substantially Equivalent |
| K003121 | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS | Oct 20, 2000 | Substantially Equivalent |
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 1, 2000 | Substantially Equivalent |
| K000030 | SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 19, 2000 | Substantially Equivalent |
| K993517 | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION | Nov 2, 1999 | Substantially Equivalent |