ClearanceBrief
Panels › Radiology › Product code JAK · Class 2

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)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Dec 18, 2023Philips 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
JAKK180015
K212441
Nov 16, 2023Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Open, Classified
JAKK212875
Nov 15, 2023Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Open, Classified
JAKK212875
Nov 14, 2023Philips 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
JAKK171850
Nov 14, 2023Philips 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
JAKK171850
Nov 14, 2023Philips 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
JAKK171850
Sep 30, 2023Philips Healthcare
Incisive CT, software version 5.0
Open, Classified
JAKK180015
K211168 +1
Sep 29, 2023Olympus 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
JAKK093146
K122106 +1
Sep 29, 2023Olympus 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
JAKK093146
K122106 +1
Sep 29, 2023Olympus 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
JAKK093146
K122106 +1
Sep 29, 2023Olympus 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
JAKK093146
K122106 +1
Sep 29, 2023Olympus 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
JAKK170023
Sep 29, 2023Olympus 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
JAKK093146
K122106 +1
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Olympus 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
JAKK122106
K170023
Jul 28, 2023Philips North America
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Open, Classified
JAKK180015
Jul 28, 2023Philips North America
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Open, Classified
JAKK180015
Jul 28, 2023Philips North America
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Open, Classified
JAKK180015
Jul 28, 2023Philips North America
Incisive CT-Computed Tomography X-Ray System Model: 728143
Open, Classified
JAKK180015
Jul 3, 2023NeuroLogica 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
JAKK171183
K202526
Jun 26, 2023Covidien, LLC
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Open, Classified
JAKK191394
May 23, 2023PHILIPS HEADQUARTERS CAMBRIDGE
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Open, Classified
JAKK180015
K212441
May 23, 2023PHILIPS HEADQUARTERS CAMBRIDGE
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Open, Classified
JAKK180015
K212441
May 23, 2023PHILIPS HEADQUARTERS CAMBRIDGE
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Open, Classified
JAKK180015
K212441
May 23, 2023PHILIPS HEADQUARTERS CAMBRIDGE
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Open, Classified
JAKK180015
K212441
May 12, 2023Philips North America
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Open, Classified
JAKK180015
K212441
May 12, 2023Philips North America
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Open, Classified
JAKK180015
K212441
May 12, 2023Philips North America Llc
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Open, Classified
JAKK203020
Feb 7, 2023Olympus Corporation of the Americas
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Open, Classified
JAKK170023
Jan 20, 2023Siemens 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
JAKK200524
K211373 +1
Jan 17, 2023Mobius Imaging, LLC
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Open, Classified
JAKK180393
Dec 6, 2022Mobius Imaging, LLC
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Terminated
JAKK180393
Aug 26, 2022Siemens 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
JAKK181407
Jul 12, 2022FUJIFILM Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
Open, Classified
JAKK183291
Jul 12, 2022FUJIFILM Healthcare Americas Corporation
Surpria: Software Version V3.11, V3.22
Open, Classified
JAKK183291
Jul 12, 2022FUJIFILM Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Open, Classified
JAKK213829
May 20, 2022Siemens Medical Solutions USA, Inc
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Open, Classified
JAKK193326
Apr 5, 2022GE Healthcare, LLC
Revolution CT, Revolution CT ES
Open, Classified
JAKK133705
K163213 +1
Apr 5, 2022GE Healthcare, LLC
Revolution Apex, Revolution CT with Apex Edition
Open, Classified
JAKK163213
K191777
Mar 7, 2022Siemens 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
JAKK200524
Mar 7, 2022Siemens 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
JAKK200524
Mar 7, 2022Siemens 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
JAKK211373
Mar 7, 2022Siemens 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
JAKK163296
K173632 +3
Nov 24, 2021GE Healthcare, LLC
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Open, Classified
JAKK133705
K163213 +1

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