510(k) K193215
- Device
- Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems
- Applicant
- Philips Medical Systems Nederland BV
- 510(k) number
- K193215
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-10
- Date received
- 2019-11-21
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jan Van de Kerkhof
- Address
- Veenpluis 4-6 Best Noord-Brabant NL 5684 pc 5684 pc
FDA Registration Numbers#
- 3010398867
- 2520313
- 3010703925
- 3020162557
- 3004531751
- 3011015597
- 3002808157
- 3014635027
- 2126677
- 1721113
- 3015276088
- 3004929307
- 3011106828
- 3006015847
- 1723170
- 3007546534
- 3006239787
- 3014809646
- 1650907
- 3010009632
- 3023385454
- 9614698
- 3004977335
- 1826555
- 3027339477
- 3012939903
- 3009963139
- 3006738448
- 1526534
- 3011416394
- 3026391023
- 3014343100
- 3016851825
- 1063285
- 3009154005
- 3009882464
- 3018094310
- 3008447096
- 3014111222
- 3011950073
- 3009715136
- 3012354318
- 3036666444
- 2432211
- 3005517190
- 3027373189
- 2029299
- 3033527281
- 1835830
- 3017297314
- 3031503890
- 3003768277
- 3007545404
- 9617016
- 9613936
- 3016727312
- 3013343065
- 3000126629
- 3006849754
- 3005326970
- 3010701021
- 3033536331
- 3008632256
- 1221108
- 3007562060
- 3017375271
- 3012439308
- 3011767965
- 1054713
- 3006073271
- 1055916
- 3014232555
- 3012761544
- 3009714754
- 3006621332
- 3019595609
- 3005877899
- 8043485
- 1319639
Source Documents#
Other 510(k) Records For Product Code LNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-09-01 |
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2026-08-19 |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | 2026-08-17 |
| K253808 | AIR Recon DL | GE Medical Systems | 2026-08-13 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | 2026-07-31 |
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | 2026-07-31 |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2026-03-27 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 |
| 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 |
Legacy Summary#
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
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