FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Halifax Imaging Kit
K Number: K182880
·
Decision Oct 31, 2018
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
347
Applicant Total
1
Review Days
16
Basic Information
- Device Name
- Halifax Imaging Kit
- K Number
- K182880
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Halifax Biomedical, Inc.
- Date Received
- October 15, 2018
- Decision Date
- October 31, 2018
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPR), ordered by most recent decision date.
GXR-Series Diagnostic X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
FDA 510(k)
FDA Class 2
·Radiology
INNOVISION-EXII
FDA 510(k)
FDA Class 2
·Radiology
uDR 780i
FDA 510(k)
FDA Class 2
·Radiology
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
FDA 510(k)
FDA Class 2
·Radiology
Definium Pace Select ET
FDA 510(k)
FDA Class 2
·Radiology