510(k) K951681
- Device
- QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
- Applicant
- FONAR CORP.
- 510(k) number
- K951681
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-11-09
- Date received
- 1995-04-11
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ANTHONY GIAMBALVO
- Address
- 110 Marcus Dr. Melville NY US 11747 11747
FDA Registration Numbers
- 3008447096
- 3005877899
- 3005049692
- 3008986341
- 3011657336
- 1932738
- 3021059265
- 3032109181
- 3003661577
- 1055916
- 3030982377
- 1054713
- 3003494057
- 3015431711
- 3018423337
- 9613936
- 3042177665
- 3009077524
- 3015329423
- 3016591365
- 3002808157
- 3008632256
- 9614698
- 3015232217
- 3007350713
- 3011015597
- 3009154005
- 3020162557
- 3009504230
- 3014809646
- 3014310698
- 3006369484
- 9617277
- 3006262888
- 3036666444
- 3027339477
- 3004531751
- 3007545404
- 3007546534
- 3029521953
- 3026391023
- 3014343100
- 3004859018
- 3010009632
- 3011416394
- 3012169560
- 3011767965
- 3005810333
- 3033536331
- 1826555
- 1221108
- 3011950073
- 1529041
- 3012354318
- 3006073271
- 3012939903
- 3007734888
- 3019844073
- 3013679558
- 3012439308
- 1058584
- 3013695852
- 3017375271
- 3006239787
- 3004754211
- 3012085143
- 3010949642
- 9611343
- 1723170
- 3003768277
- 3006621332
- 2126677
- 3015276088
- 3017297314
- 3010398867
- 1526534
- 1319639
- 3013875850
- 3010703925
Source Documents
510(k) summary PDF not indicated by FDA
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Legacy Summary
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FDA Review
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