DEVICE: PICA Whole-body MRI System (00862694000304)
Device Identifier (DI) Information
PICA Whole-body MRI System
TMS-MRI-3500wb-02
In Commercial Distribution
TIME MEDICAL SYSTEMS
TMS-MRI-3500wb-02
In Commercial Distribution
TIME MEDICAL SYSTEMS
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37652 | Full-body MRI system, permanent magnet |
A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LNH | System, Nuclear Magnetic Resonance Imaging |
MOS | Coil, Magnetic Resonance, Specialty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110942 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: less than 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 20 and 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 18500 Kilogram |
Device Record Status
ddacc532-6311-4607-a3f8-589dea246964
March 15, 2023
4
September 27, 2016
March 15, 2023
4
September 27, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 858-458-0166
sales@time-medical.com +1 650-689-5289
sales@time-medical.com
sales@time-medical.com +1 650-689-5289
sales@time-medical.com