FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC ULTRASOUND TRANSDUCER
K Number: K953759
·
Decision Mar 1, 1996
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
39
Review Days
203
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Basic Information
- Device Name
- DIAGNOSTIC ULTRASOUND TRANSDUCER
- K Number
- K953759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosound, Inc.
- Date Received
- August 11, 1995
- Decision Date
- March 1, 1996
- 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
FDA 510(k)
FDA Class 2
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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
Other Clearances by Biosound, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | Jul 9, 1997 | Substantially Equivalent |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Mar 31, 1997 | Substantially Equivalent |
| K963262 | ARTOSCAN M | Mar 28, 1997 | Substantially Equivalent |
| K963662 | GALILEO EVOKED POTENTIALRE | Feb 26, 1997 | Substantially Equivalent |
| K953716 | INTRACAVITY TRANSDUCERS | Apr 17, 1996 | Substantially Equivalent |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Apr 8, 1996 | Substantially Equivalent |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Mar 1, 1996 | Substantially Equivalent |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Feb 12, 1996 | Substantially Equivalent |
| K953579 | TEE PROBE | Feb 2, 1996 | Substantially Equivalent |
| K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Oct 24, 1995 | Substantially Equivalent |