FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VISION CARE/PHAKOSYSTEMS ECHOPACH
K Number: K880081
·
Decision Mar 15, 1988
Classifications
1
FEI Numbers
345
Registration Numbers
346
Same Product Code
883
Applicant Total
5
Review Days
64
Basic Information
- Device Name
- VISION CARE/PHAKOSYSTEMS ECHOPACH
- K Number
- K880081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- PHAKOSYSTEMS, INC.
- Date Received
- January 11, 1988
- Decision Date
- March 15, 1988
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
B-Scan
FDA 510(k)
FDA Class 2
·Radiology
Velacur One (LI-1100)
FDA 510(k)
FDA Class 2
·Radiology
Accuro 3S
FDA 510(k)
FDA Class 2
·Radiology
EchoGuide (Version 1)
FDA 510(k)
FDA Class 2
·Radiology
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
FDA 510(k)
FDA Class 2
·Radiology
SpineUs System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by PHAKOSYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K871938 | VISION CARE/PHAKOSYSTEMS ECHORULE | Nov 23, 1987 | Substantially Equivalent |
| K860236 | PHAKOSYSTEMS CT-100 CAUTERY MODULE | Feb 19, 1986 | Substantially Equivalent |
| K851674 | PHAKOSYSTEMS MODEL CES 4100 | Aug 5, 1985 | Substantially Equivalent |
| K830871 | PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION | Jun 2, 1983 | Substantially Equivalent |