FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY
K Number: K926252
·
Decision Oct 25, 1993
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
15
Review Days
315
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Basic Information
- Device Name
- CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY
- K Number
- K926252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endosonics Corp.
- Date Received
- December 14, 1992
- Decision Date
- October 25, 1993
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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|---|---|---|---|
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| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Jun 29, 1998 | Substantially Equivalent |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Aug 6, 1997 | Substantially Equivalent |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | Sep 16, 1996 | Substantially Equivalent |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | Sep 22, 1995 | Substantially Equivalent |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | May 4, 1995 | Substantially Equivalent |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | Jan 15, 1993 | Substantially Equivalent |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Jun 25, 1991 | Substantially Equivalent |