FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
K Number: K071299
·
Decision Aug 31, 2007
Classifications
1
FEI Numbers
33
Registration Numbers
34
Same Product Code
50
Applicant Total
1
Review Days
114
Basic Information
- Device Name
- IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
- K Number
- K071299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DIGITAL HEALTHCARE, LTD.
- Date Received
- May 9, 2007
- Decision Date
- August 31, 2007
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFJ), ordered by most recent decision date.
iCare ALTIUS CW
FDA 510(k)
FDA Class 2
·Radiology
IMAGEnet6 Ophthalmic Data System
FDA 510(k)
FDA Class 2
·Radiology
CALLISTO eye
FDA 510(k)
FDA Class 2
·Radiology
Harmony
FDA 510(k)
FDA Class 2
·Radiology
CALLISTO eye
FDA 510(k)
FDA Class 2
·Radiology
Altris IMS
FDA 510(k)
FDA Class 2
·Radiology