510(k) K011485
- Device
- PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
- Applicant
- FONAR CORP.
- 510(k) number
- K011485
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-06
- Date received
- 2001-05-15
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- LUCIANO BONANNI
- Address
- 110 Marcus Dr., 102 Marcus Dr. & 405 Smith St. 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
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- 3004531751
- 3007545404
- 3007546534
- 3029521953
- 3026391023
- 3014343100
- 3004859018
- 3010009632
- 3011416394
- 3012169560
- 3011767965
- 3005810333
- 3033536331
- 1826555
- 1221108
- 3011950073
- 1529041
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- 3007734888
- 3019844073
- 3013679558
- 3012439308
- 1058584
- 3013695852
- 3017375271
- 3006239787
- 3004754211
- 3012085143
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- 9617016
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- 3023003446
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- 3027373189
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- 3012127758
- 3023385454
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- 3009715136
- 3009882464
- 3006015847
- 3018094310
- 3021593788
- 2134213
- 3009714754
- 3026047529
Source Documents
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| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| K253780 | SIGNA Bolt | Ge Medical Systems, LLC | 2026-02-06 |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | 2026-02-05 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026-01-26 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | 2025-12-19 |
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Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases