FDA Registration
Active
🇺🇸 United States
PICA Whole-Body MRI System
Reg #: 3008298501
·
FEI: 3008298501
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Time Medical Systems Inc.
- Registration Number
- 3008298501
- FEI Number
- 3008298501
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 890 Cowan Road, Suite J
- City
- Burlingame
- State
- CA
- ZIP
- 94010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110942
Owner / Operator
- Firm Name
- Time Medical Limited
- Operator Number
- 10031087
- Address
- FLAT/RM G02 G/F MARS CENTRE, 2 DAI WANG STREET, TAI PO INDUSTRIAL EST
- City
- NT
- State
- Hong Kong
- Postal Code
- 0
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2011-12-09 |
Proprietary Names
PICA Whole-Body MRI System
Establishment Types
Repack or Relabel Medical Device