FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K Number: K883699
·
Decision Oct 31, 1988
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
12
Review Days
62
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Basic Information
- Device Name
- B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
- K Number
- K883699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Fonar Corp.
- Date Received
- August 30, 1988
- Decision Date
- October 31, 1988
- 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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| K951681 | QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER | Nov 9, 1995 | Substantially Equivalent |
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| K920789 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | Jun 25, 1992 | Substantially Equivalent |
| K915567 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY) | May 15, 1992 | Substantially Equivalent |
| K910839 | ULTIMATE 3000 | Jul 26, 1991 | Substantially Equivalent |