FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
K Number: K061930
·
Decision Jul 28, 2006
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
12
Review Days
21
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Basic Information
- Device Name
- INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
- K Number
- K061930
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fonar Corp.
- Date Received
- July 7, 2006
- Decision Date
- July 28, 2006
- 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 Fonar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011485 | PINNACLE MAGNETIC RESONANCE IMAGING SCANNER | Jun 6, 2001 | Substantially Equivalent |
| K003453 | SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS | Jan 18, 2001 | Substantially Equivalent |
| K002490 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER | Oct 3, 2000 | Substantially Equivalent |
| K994287 | FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER | Mar 16, 2000 | Substantially Equivalent |
| K951681 | QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER | Nov 9, 1995 | Substantially Equivalent |
| K940772 | ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER) | Apr 10, 1995 | Substantially Equivalent |
| 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 |
| K883699 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | Oct 31, 1988 | Substantially Equivalent |