FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIZION ULTRA
K Number: K133139
·
Decision Apr 3, 2014
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
418
Applicant Total
4
Review Days
168
Basic Information
- Device Name
- VIZION ULTRA
- K Number
- K133139
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VIZTEK LLC
- Date Received
- October 17, 2013
- Decision Date
- April 3, 2014
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQB), ordered by most recent decision date.
SKR 3000
FDA 510(k)
FDA Class 2
·Radiology
Wireless/ Wired X-Ray Flat Panel Detectors
FDA 510(k)
FDA Class 2
·Radiology
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
FDA 510(k)
FDA Class 2
·Radiology
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
FDA 510(k)
FDA Class 2
·Radiology
Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
FDA 510(k)
FDA Class 2
·Radiology
ExamVue Apex
FDA 510(k)
FDA Class 2
·Radiology