FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUSON MODEL 3001
K Number: K935595
·
Decision Mar 2, 1995
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
37
Review Days
468
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Basic Information
- Device Name
- ACUSON MODEL 3001
- K Number
- K935595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acuson Corp.
- Date Received
- November 19, 1993
- Decision Date
- March 2, 1995
- Product Code
- ITX
- 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 |
|---|---|---|---|
| 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.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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| K973767 | HARMONIC IMAGING WITH CONTRAST | Dec 23, 1997 | Substantially Equivalent |