FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXART V3.5 SOFTWARE
K Number: K970573
·
Decision Jul 21, 1997
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
68
Review Days
157
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Basic Information
- Device Name
- FLEXART V3.5 SOFTWARE
- K Number
- K970573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toshiba America Mri, Inc.
- Date Received
- February 14, 1997
- Decision Date
- July 21, 1997
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by Toshiba America Mri, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 | Oct 26, 2000 | Substantially Equivalent |
| K002522 | OPART, MODEL MRT-600 | Oct 25, 2000 | Substantially Equivalent |
| K000549 | OPART, MODEL MRT-600 | Apr 20, 2000 | Substantially Equivalent |
| K993803 | EXCELART WITH PIANISSIMO | Feb 6, 2000 | Substantially Equivalent |
| K993574 | OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON | Jan 18, 2000 | Substantially Equivalent |
| K991740 | OPART, MODEL MRT-600 | Aug 2, 1999 | Substantially Equivalent |
| K991057 | EXTRA LARGE BODY COIL FOR OPART (MRT-600) | May 20, 1999 | Substantially Equivalent |
| K990620 | EXCELART | May 14, 1999 | Substantially Equivalent |
| K990260 | OPART | Apr 15, 1999 | Substantially Equivalent |
| K990007 | OPART, MODEL MRT-600 | Apr 1, 1999 | Substantially Equivalent |