510(k) K070968
- Device
- CHOY COMPRESSION FRAME
- Applicant
- CHOY MEDICAL TECHNOLOGIES, INC.
- 510(k) number
- K070968
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-15
- Date received
- 2007-04-05
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN S KAHAN
- Address
- 555 Thirteenth St., NW Columbia Sq. Washington DC US 20004 20004
FDA Registration Numbers#
- 3014111222
- 3006621332
- 1054713
- 3036666444
- 3010949642
- 3005049692
- 3015431711
- 3018423337
- 3005450718
- 1529041
- 3012354318
- 9614698
- 2011171
- 1221108
- 3004977335
- 2247992
- 2520313
- 3016727312
- 3003661577
- 3021059265
- 3004929307
- 3011015597
- 3005517190
- 2183553
- 3026047529
- 3003494057
- 3004526608
- 3027373189
- 3015276088
- 3009714754
- 3009715136
- 3015223550
- 3009755250
- 1721113
- 3003768277
- 3035950510
- 3013695852
- 3019844073
- 3006073271
- 3014680716
- 2134213
- 3012085143
- 3015329423
- 3014310698
- 3019595609
- 3011106828
- 3010701021
- 3009154005
- 1650907
- 3005326970
- 3033536331
- 3010009632
- 3018094310
- 1063285
- 3008496839
- 3012169560
- 3009963139
- 3034286426
- 1526534
- 3012939903
- 3009882464
- 1058584
- 3012075008
- 3017375271
- 9611343
- 3033333119
- 3013875850
- 3027339477
- 3014232555
- 3008447096
- 2029299
- 3000126629
- 3005877899
- 3008284470
- 3007546534
- 3025602463
- 3015232217
- 3018004899
- 3004531751
Source Documents#
Other 510(k) Records For Product Code LNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262902 | ECHELON Synergy | Fujifilm Corporation | 2026-10-09 |
| K260092 | Vista AI Scan | Vista AI, Inc. | 2026-10-07 |
| K261612 | SwiftSight-BodyComposition | Airs Medical, Inc. | 2026-10-01 |
| K261283 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-09-16 |
| K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | 2026-09-16 |
| 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 |
Legacy Summary#
summary
FDA Review#
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