FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPAL CHIRO, 20/20 P-DR
K Number: K141435
·
Decision Aug 27, 2014
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
418
Applicant Total
1
Review Days
89
Basic Information
- Device Name
- OPAL CHIRO, 20/20 P-DR
- K Number
- K141435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 2020 IMAGING
- Date Received
- May 30, 2014
- Decision Date
- August 27, 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