FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
PICA WHOLE BODY MRI SYSTEM
K Number: K091580
·
Decision Jul 24, 2009
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
6
Review Days
52
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Basic Information
- Device Name
- PICA WHOLE BODY MRI SYSTEM
- K Number
- K091580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Time Medical Limited
- Date Received
- June 2, 2009
- Decision Date
- July 24, 2009
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by Time Medical Limited
| K Number | Device Name | ||
|---|---|---|---|
| K222259 | NEONA 1.5T MRI System | Feb 21, 2023 | Substantially Equivalent |
| K183621 | EMMA 1.5T MRI System | Feb 22, 2019 | Substantially Equivalent |
| K110942 | PICA WHOLE-BODY MRI SYSTEM | Jul 26, 2011 | Substantially Equivalent |
| K093984 | PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 | Mar 24, 2010 | Substantially Equivalent |
| K092230 | MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 | Nov 25, 2009 | Substantially Equivalent |