FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADDITIONAL TRANSDUCERS FOR USE W/SDL 300
K Number: K897073
·
Decision Aug 21, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
49
Review Days
242
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Basic Information
- Device Name
- ADDITIONAL TRANSDUCERS FOR USE W/SDL 300
- K Number
- K897073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Shimadzu Corp.
- Date Received
- December 22, 1989
- Decision Date
- August 21, 1990
- 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)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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FDA Class 2
·Radiology
Mendaera Guidance System
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Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
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