510(k) K884668
- Device
- EXEL 1002 CT SCANNER
- Applicant
- ELSCINT, INC.
- 510(k) number
- K884668
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-30
- Date received
- 1988-11-08
- Regulation
- 892.1750
- Classification name
- System, X-ray, Tomography, Computed
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SOBEL
- Address
- 930 Commonwealth Ave. Boston MA US 02215 02215
FDA Registration Numbers#
- 3006621332
- 1054713
- 3003094912
- 3036666444
- 3008007310
- 3017426576
- 3011825597
- 3018423337
- 9614698
- 2011171
- 3016007746
- 1034973
- 2247992
- 2183744
- 3004977335
- 2520313
- 3019216
- 3021059265
- 3004857110
- 3006487372
- 3011015597
- 3016248538
- 3015537315
- 3026047529
- 3004962788
- 3014653800
- 3005930550
- 3011642792
- 3011050570
- 3007233544
- 3027373189
- 3006894636
- 3007797756
- 3004993756
- 3015276088
- 3014938447
- 3010642685
- 9612283
- 3015223550
- 9613445
- 1317307
- 3003768277
- 3035950510
- 1811755
- 3003967489
- 3033527283
- 3011797532
- 2134213
- 3012085143
- 3043512431
- 1226188
- 8043728
- 1000246715
- 3004091527
- 3009154005
- 3033527273
- 3042175844
- 3007225492
- 3015169361
- 3004198450
- 3018094310
- 3006610845
- 3012044688
- 3008496839
- 3018596740
- 3009963139
- 3017500061
- 3010281549
- 3033524251
- 3014134519
- 9613299
- 9616567
- 8043933
- 3012939903
- 3027245002
- 3017375271
- 9611343
- 3012938564
- 3002907620
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
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