510(k) K915738
- Device
- EXCEL CT TWIN
- Applicant
- ELSCINT, INC.
- 510(k) number
- K915738
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-21
- Date received
- 1991-12-20
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROCHELLE M SOBEL
- Address
- 505 Main St. Suite 300 Hackensack NJ US 07601 07601
FDA Registration Numbers#
- 3032109181
- 1811755
- 3006487372
- 8043933
- 3014809646
- 3006610845
- 3007562060
- 3000126629
- 3005156333
- 3026047529
- 3006209933
- 3033527273
- 3010151377
- 3033527241
- 3015223550
- 3023460764
- 3029521953
- 1317307
- 3027339477
- 3009543051
- 9617978
- 3017425975
- 3004938766
- 3011786147
- 3007797756
- 3004753774
- 3013679558
- 3003477135
- 3014653800
- 9616567
- 3033527282
- 3031503890
- 3003678543
- 3013035022
- 3003967489
- 3019216
- 3008496839
- 2134850
- 3011825597
- 8022257
- 9614698
- 3017375271
- 3011797532
- 3009963139
- 3011050570
- 1123169
- 9612283
- 1226188
- 3035950510
- 3010123525
- 1834003
- 3008284470
- 2183744
- 3030982377
- 3010789868
- 3008007310
- 3033527283
- 3011802799
- 2247992
- 3009154005
- 3017894900
- 3013847349
- 3027245002
- 3009196578
- 3015276088
- 3014938447
- 3012453401
- 3016007746
- 3017426576
- 3003094912
- 3016248538
- 3012957335
- 3005877899
- 3014134519
- 2030624
- 3039211310
- 8043728
- 3009077524
- 3032109225
Source Documents#
510(k) summary PDF not indicated by FDA
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| 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 |
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