510(k) K113548
- Device
- PEDCAT
- Applicant
- CURVEBEAM, LLC
- 510(k) number
- K113548
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-10
- Date received
- 2011-12-01
- 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
- No
Applicant Contact#
- Contact
- DAVID W COWAN
- Address
- 175 Titus Ave. Suite 300 Warrington PA US 18976 18976
FDA Registration Numbers#
- 3017425975
- 3039211310
- 2032112
- 3009077524
- 1066019
- 3023460764
- 3010123525
- 3042172882
- 3000126629
- 3012453401
- 3026047529
- 3008355361
- 3011786147
- 3010642685
- 3027338963
- 3015060224
- 1317307
- 3030982377
- 3016007746
- 3009529630
- 9613299
- 3014938447
- 3016619943
- 3006209933
- 3015777306
- 2126677
- 3003477135
- 3027339477
- 3014343100
- 3014809646
- 3035950510
- 3008007310
- 3015232217
- 3017210169
- 3003967489
- 1811755
- 3008284470
- 2183744
- 3002807636
- 3007562060
- 3004993756
- 3018423337
- 3009196578
- 3033527282
- 3004857110
- 3026391023
- 3004083736
- 9617978
- 3006487372
- 3007797756
- 3004938766
- 3033527241
- 3015276088
- 3011396687
- 3012957335
- 3033527283
- 9611343
- 3003202425
- 3010398867
- 3004962788
- 3019216
- 1054713
- 1423253
- 3003575350
- 3012939903
- 2520313
- 3005156333
- 3031503890
- 3036666444
- 3008632256
- 9616567
- 8043933
- 3010151377
- 3013875850
- 3010703925
- 3011825597
- 3009543051
- 3011797532
- 2030624
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 |
Legacy Summary#
summary
FDA Review#
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