510(k) K260391
- Device
- AVIEW Aorta Metrics
- Applicant
- Coreline Soft Co., Ltd.
- 510(k) number
- K260391
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-16
- Date received
- 2026-02-06
- Regulation
- 892.1750
- Classification name
- System, X-Ray, Tomography, Computed
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hyeyi Park
- Address
- 12, Donggyo-Ro 19-Gil, Mapo-Gu Seoul KR 04001 04001
FDA Registration Numbers#
- 3016007746
- 8022257
- 3011802799
- 3016248538
- 3016965352
- 3013679558
- 3009963139
- 3008284470
- 2032112
- 3017375271
- 9611343
- 3032109181
- 3033524251
- 3015537315
- 3014938447
- 3004753774
- 3008007310
- 3009196578
- 3010703925
- 3003202425
- 3008355361
- 3011050570
- 3006209933
- 8043728
- 3012957335
- 3014809646
- 3010123525
- 3013847349
- 1000246715
- 3011825597
- 3006487372
- 3011642792
- 3011015597
- 3003094912
- 3012453401
- 2126677
- 3011786147
- 3008632256
- 3030982377
- 3004993756
- 3012085143
- 1226188
- 1054713
- 9617978
- 2134850
- 3042175844
- 9616567
- 3017210169
- 3010398867
- 2520313
- 3019216
- 3015763655
- 3004198450
- 3023003446
- 3014246639
- 3003678543
- 3012044688
- 3042172882
- 3014343100
- 3033527283
- 3005156333
- 3015276088
- 3012761544
- 3008769756
- 3023460764
- 3027339477
- 2134243
- 3015223550
- 3036666444
- 3032109225
- 9613445
- 3010789868
- 3006621332
- 3004083736
- 3035950510
- 9613299
- 3007562060
- 3011396687
- 3009154005
Source Documents#
Other 510(k) Records For Product Code JAK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261225 | CAS-One IR | Cascination AG | 2026-09-29 |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | 2026-09-22 |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | 2026-09-18 |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | 2026-09-04 |
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026-07-21 |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026-06-24 |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026-06-04 |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 |