FDA Registration
Active
🇨🇦 Canada
Flat Panel Detector
Reg #: 3016256852
·
FEI: 3016256852
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KA IMAGING INC.
- Registration Number
- 3016256852
- FEI Number
- 3016256852
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 560 Parkside Drive #3
- City
- Waterloo Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K201591
Owner / Operator
- Firm Name
- KA Imaging Inc.
- Operator Number
- 10078351
- Address
- 560 Parkside Drive #3
- City
- Waterloo
- State
- Ontario
- Postal Code
- N2L 5Z4
- Country
- CA
- Correspondent
- Amol Karnick
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2020-10-19 |
Proprietary Names
Flat Panel Detector
Reveal 35C
Establishment Types
Manufacture Medical Device