510(k) K111024
- Device
- JETPACK 2.0
- Applicant
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- 510(k) number
- K111024
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-04-21
- Date received
- 2011-04-12
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- LORI R PETERSON
- Address
- 3860 N. 1st St. San Jose CA US 95134 95134
FDA Registration Numbers#
- 1226188
- 3007137598
- 3001675293
- 3003781339
- 3015169361
- 3025343020
- 8022257
- 3042248552
- 3003596442
- 3008496839
- 8030233
- 3007305589
- 3010146120
- 3024078470
- 3019216
- 3038177848
- 9617592
- 3021233709
- 9617840
- 3005778458
- 3032008018
- 2183301
- 3015777306
- 3017058304
- 3007675959
- 9614209
- 3027158439
- 3018405359
- 3005945241
- 3005860720
- 3008596921
- 3021032044
- 3012448806
- 3010132318
- 3017435704
- 3009144915
- 3024040179
- 3015961056
- 3009149931
- 3010966991
- 3033525986
- 3011545155
- 3014665798
- 3006165530
- 3030179922
- 3006165260
- 3006551230
- 3003895711
- 3014398772
- 3011706018
- 3017448360
- 3029906636
- 3020858025
- 3010601176
- 3035371452
- 3014470527
- 3011853771
- 3009833070
- 3017263724
- 3007734888
- 3035455070
- 3027977501
- 3010533307
- 3004756607
- 3008837339
- 3023546785
- 1064588
- 9615010
- 9610482
- 3017004860
- 3007005340
- 9681475
- 9680028
- 1825014
- 3005383085
- 3044519982
- 3016954909
- 3013511605
- 3021625328
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
Legacy Summary#
summary
FDA Review#
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