System, X-Ray, Tomography, Computed
Regulation 892.1750
22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
Top companies in JAK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2023 | Philips North America Llc The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system a Completed |
JAK | K180015 K212441 |
| Nov 16, 2023 | Philips North America Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Open, Classified |
JAK | K212875 |
| Nov 15, 2023 | Philips North America Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Open, Classified |
JAK | K212875 |
| Nov 14, 2023 | Philips North America Llc Brilliance CT Big Bore Oncology with software version V4.8.0.10421
Model:728243
CT scanner and simulator designed for radiation oncology and therapy. Open, Classified |
JAK | K171850 |
| Nov 14, 2023 | Philips North America Llc Brilliance CT Big Bore with software version V4.8.0.10421
Model:728244
CT scanner and simulator designed for radiation oncology and therapy. Open, Classified |
JAK | K171850 |
| Nov 14, 2023 | Philips North America Llc Big Bore RT with software version V4.8.0.10421- Model: 728242
CT scanner and simulator designed for radiation oncology and therapy. Open, Classified |
JAK | K171850 |
| Sep 30, 2023 | Philips Healthcare Incisive CT, software version 5.0 Open, Classified |
JAK | K180015 K211168 +1 |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Endobronchial Always on Track
Models:
INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX
INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx
INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx Open, Classified |
JAK | K093146 K122106 +1 |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Percutaneous Always on Track
Models:
INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga
INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga
INS-5036 "22 UTW 125mm Always- Open, Classified |
JAK | K093146 K122106 +1 |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Endobronchial
Models:
INS-5500 View Optical Probe
INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx
INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC
INS-5411 0.016" Stylet, 1235 mm L, Open, Classified |
JAK | K093146 K122106 +1 |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Percutaneous
Models:
INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)"
INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx
INS-5610 SPiN Perc Localization N Open, Classified |
JAK | K093146 K122106 +1 |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran Endobronchial:
Models:
INS-5925 SPiN Access Catheter 180 Degree for use w/ Pentax Scopes
INS-5920 SPiN Access Catheter 90 Degree for use w/ Pentax Scopes
INS-5915 SPiN Access Catheter 18 Open, Classified |
JAK | K170023 |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran:SPiN Thoracic Navigation System
Models:
SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz
SYS-4000 SPiN Thoracic Navigation System
SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Na Open, Classified |
JAK | K093146 K122106 +1 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga
Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscop Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography an Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/ Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomograph Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomograp Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or end Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endosc Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD
Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic Open, Classified |
JAK | K122106 K170023 |
| Jul 28, 2023 | Philips North America Incisive CT Plus-Computed Tomography X-Ray System
Model: 728149 Open, Classified |
JAK | K180015 |
| Jul 28, 2023 | Philips North America Incisive CT Power (China)-Computed Tomography X-Ray System
Model: 728148 Open, Classified |
JAK | K180015 |
| Jul 28, 2023 | Philips North America Incisive CT for Brazil SKD-Computed Tomography X-Ray System
Model: 728146 Open, Classified |
JAK | K180015 |
| Jul 28, 2023 | Philips North America Incisive CT-Computed Tomography X-Ray System
Model: 728143 Open, Classified |
JAK | K180015 |
| Jul 3, 2023 | NeuroLogica Corporation OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck
Model Number: NL5000 Open, Classified |
JAK | K171183 K202526 |
| Jun 26, 2023 | Covidien, LLC Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Open, Classified |
JAK | K191394 |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System
Model Number: 728149 (OUS) Open, Classified |
JAK | K180015 K212441 |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT Power- Whole-body computed tomography (CT) X-Ray System
Model Number: 728148 (OUS) Open, Classified |
JAK | K180015 K212441 |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- Whole-body computed tomography (CT) X-Ray System
Model Number: 728143 (OUS) Open, Classified |
JAK | K180015 K212441 |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- whole-body computed tomography (CT) X-Ray System
Model Number: 728144 Open, Classified |
JAK | K180015 K212441 |
| May 12, 2023 | Philips North America Philips Incisive CT -Computed Tomography X-Ray System
Model Number: 72813 Open, Classified |
JAK | K180015 K212441 |
| May 12, 2023 | Philips North America Philips Incisive CT -Computed Tomography X-Ray System
Model Number: 72814 Open, Classified |
JAK | K180015 K212441 |
| May 12, 2023 | Philips North America Llc Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 Open, Classified |
JAK | K203020 |
| Feb 7, 2023 | Olympus Corporation of the Americas SPiN Thoracic Navigation System
Model: SYS-4000 (SYS-4000D) Open, Classified |
JAK | K170023 |
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc Software :
myNeedle Guide 2D license,
myNeedle Guide 2D AWP only Workflow license, or
myNeedle Guide 3D license.
Used on the following CT (Computed tomography systems):
SOMATOM go.Now Model 11061610 Open, Classified |
JAK | K200524 K211373 +1 |
| Jan 17, 2023 | Mobius Imaging, LLC MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. Open, Classified |
JAK | K180393 |
| Dec 6, 2022 | Mobius Imaging, LLC MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 Terminated |
JAK | K180393 |
| Aug 26, 2022 | Siemens Medical Solutions USA, Inc Artis Q floor- Model No. 10848280
Artis Q ceiling- Model No. 10848281
Artis Q biplane- Model No. 10848282
Artis Q zeego- Model No. 10848283
Artis Q.zen floor- Model No. 10848353
Artis Q.zen ceiling- M Open, Classified |
JAK | K181407 |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation Surpria 64: Software Version V3.11, V3.22 Open, Classified |
JAK | K183291 |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation Surpria: Software Version V3.11, V3.22 Open, Classified |
JAK | K183291 |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Open, Classified |
JAK | K213829 |
| May 20, 2022 | Siemens Medical Solutions USA, Inc Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 Open, Classified |
JAK | K193326 |
| Apr 5, 2022 | GE Healthcare, LLC Revolution CT, Revolution CT ES Open, Classified |
JAK | K133705 K163213 +1 |
| Apr 5, 2022 | GE Healthcare, LLC Revolution Apex, Revolution CT with Apex Edition Open, Classified |
JAK | K163213 K191777 |
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A afte Terminated |
JAK | K200524 |
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgr Terminated |
JAK | K200524 |
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgr Terminated |
JAK | K211373 |
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc SIEMENS SOMATOM with software syngo CT VA30A_SP4
Models:
SOMATOM go.Now 11061610 & 11061618
SOMATOM go.Up 11061620 & 11061628
SOMATOM go.All 11061630 & 11061638
SOMATOM go.Top 11061640 & 1106 Open, Classified |
JAK | K163296 K173632 +3 |
| Nov 24, 2021 | GE Healthcare, LLC Computed Tomography Systems
Revolution CT,
Revolution CT ES,
Revolution Apex,
Revolution CT with Apex edition Open, Classified |
JAK | K133705 K163213 +1 |
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