FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K Number: K110999
·
Decision Apr 26, 2011
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
92
Review Days
15
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Basic Information
- Device Name
- DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K Number
- K110999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edan Instruments, Inc.
- Date Received
- April 11, 2011
- Decision Date
- April 26, 2011
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
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| K232694 | Central Monitoring System (MFM-CMS) | Feb 5, 2024 | Substantially Equivalent |