FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OASIS
K Number: K964658
·
Decision Feb 14, 1997
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
14
Review Days
86
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Basic Information
- Device Name
- OASIS
- K Number
- K964658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sonotech, Inc.
- Date Received
- November 20, 1996
- Decision Date
- February 14, 1997
- 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
Other Clearances by Sonotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | Nov 5, 2004 | Substantially Equivalent |
| K033178 | ULTRABIO | Aug 4, 2004 | Substantially Equivalent |
| K031222 | SCANLUBE | Jul 23, 2003 | Substantially Equivalent |
| K031894 | SCANTEC PAD | Jul 18, 2003 | Substantially Equivalent |
| K013701 | ENDO-GLIDE | Feb 4, 2002 | Substantially Equivalent |
| K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP | Nov 13, 2001 | Substantially Equivalent |
| K984562 | VIVOSONIC | Jun 8, 1999 | Substantially Equivalent |
| K983691 | SCANFLEX SOLID COUPLANT MEMBRANE | May 5, 1999 | Substantially Equivalent |
| K983985 | HYBRISONIC SHEATH | Feb 25, 1999 | Substantially Equivalent |
| K981028 | ULTRA IMAGE AND ULTRA SCAN | Aug 21, 1998 | Substantially Equivalent |