510(k) K891931
- Device
- QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
- Applicant
- IMAGE ANALYSIS, INC.
- 510(k) number
- K891931
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-18
- Date received
- 1989-03-28
- 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
- ARNOLD, PH.D.
- Address
- 17935 - F Skypark Cir. Irvine CA US 92714 92714
FDA Registration Numbers#
- 8043933
- 3007562060
- 3023003446
- 3013847349
- 3010398867
- 3001722928
- 3042175844
- 3003768277
- 3015763655
- 3009543051
- 2030624
- 1226188
- 3008114965
- 8043728
- 3004938766
- 3033527241
- 3006487372
- 3012938564
- 1317307
- 3010123525
- 3008496839
- 3002807636
- 3009963139
- 3010642685
- 3013875850
- 3011015597
- 3008769756
- 3017375271
- 3021059265
- 3007797756
- 8022257
- 3006894636
- 1000246715
- 3036666444
- 3006209933
- 3010326005
- 3016248538
- 3012044688
- 3005810333
- 2134213
- 3014343100
- 3007225492
- 1034973
- 3018423337
- 3004056159
- 3009196578
- 3026391023
- 9617978
- 3016007746
- 3004962788
- 2134850
- 3017426576
- 3019216
- 9613445
- 3003678543
- 3023140882
- 3004091527
- 3031503890
- 3007545404
- 2520313
- 3003575350
- 3017500061
- 2183744
- 3043512431
- 3011797532
- 3011050570
- 3027339477
- 1047843
- 1423253
- 3010601176
- 9616567
- 3015169361
- 3027373189
- 3015232217
- 3005877899
- 3015060224
- 3015777306
- 3015537315
- 3006610845
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