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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

Decided510(k)Device and applicantCode
Feb 14, 1992K915623SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
Shimadzu Medical Systems
JAK
Jan 23, 1992K913485CT SYTEC 8000
General Electric Co.
JAK
Nov 29, 1991K913352C-150 ULTRAFAST CT SCANNER
Imatron, Inc.
JAK
Nov 22, 1991K913996COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
Siemens Medical Solutions USA, Inc.
JAK
Oct 15, 1991K913029GYROVIEW-HR
Philips Medical Systems, Inc., NL
JAK
Sep 27, 1991K912454KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
Eastman Kodak Company
JAK
Sep 23, 1991K911764IMAC2000
Medical Imaging Technologies, Inc.
JAK
Sep 6, 1991K913491VORTECH'S PERSONAL DISPLAY SYSTEM
Vortech Data, Inc.
JAK
Sep 6, 1991K912752PHILIPS TOMOSCAN SR
Philips Medical Systems North America, Inc.
JAK
Aug 26, 1991K913252LITEBOX
Siemens Gammasonics, Inc.
JAK
Jul 17, 1991K911501SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
Shimadzu Medical Systems
JAK
Jul 17, 1991K911500SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
Shimadzu Medical Systems
JAK
May 17, 1991K910859COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
Siemens Medical Solutions USA, Inc.
JAK
May 9, 1991K911387CT SYTEC 4000
GE Medical Systems
JAK
Mar 15, 1991K910375HELICAL SCAN
Toshiba America Medical Systems, In.C
JAK
Jan 14, 1991K904971CT HILIGHT ADVANTAGE II
GE Medical Systems
JAK
Nov 7, 1990K903701XPRESS
Toshiba America Medical Systems, In.C
JAK
Nov 2, 1990K903763COMPUTED TOMOGRAPHY X-RAY SYSTEM
General Electric Co.
JAK
Oct 29, 1990K903622CT GUIDE (TM)
Radi Medical Systems AB, SE
JAK
Aug 17, 1990K902557XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
Toshiba America Medical Systems, In.C
JAK
Aug 1, 1990K902848FASTRECON 88 PERIFERAL
Scientific Technology , Ltd.
JAK
Jul 25, 1990K900170MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
Elscint, Inc.
JAK
Jul 9, 1990K902643FALCON DISK DRIVE SUBSYSTEM
Sokar, Inc.
JAK
Mar 13, 1990K900660TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
Philips Medical Systems North America, Inc.
JAK
Mar 8, 1990K896456TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
Toshiba America Medical Systems, In.C
JAK
Feb 26, 1990K900233TCT-300S - UPGRADE
Toshiba America Medical Systems, In.C
JAK
Jan 23, 1990K894888SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
Shimadzu Medical Systems
JAK
Dec 14, 1989K894887SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
Shimadzu Medical Systems
JAK
Sep 7, 1989K894542ELSCINT'S EXEL 2400E CT SCANNER
Elscint, Inc.
JAK
Sep 1, 1989K894269CT HILIGHT ADVANTAGE
GE Medical Systems
JAK
Aug 7, 1989K893820CT SYTEC 3000
General Electric Co.
JAK
May 18, 1989K891931QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
Image Analysis, Inc.
JAK
Feb 27, 1989K884788TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
Toshiba Medical Systems
JAK
Feb 27, 1989K884555TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
Toshiba Medical Systems
JAK
Feb 9, 1989K8853223D/DENTAL
Columbia Scientific, Inc.
JAK
Jan 18, 1989K884671EXEL 2400 AND 2400 ELITE CT SCANNERS
Elscint, Inc.
JAK
Jan 18, 1989K884670EXEL 1800 AND 1800E CT SCANNER
Elscint, Inc.
JAK
Dec 30, 1988K884669EXEL 2002 & 2002FS CT SCANNER
Elscint, Inc.
JAK
Dec 30, 1988K884668EXEL 1002 CT SCANNER
Elscint, Inc.
JAK
Dec 30, 1988K884667EXEL 905 SERIES CT SCANNER
Elscint, Inc.
JAK
Dec 20, 1988K884268VOXELSCOPE(TM)
Dynamic Digital Displays, Inc.
JAK
Oct 19, 1988K881305TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
Toshiba Medical Systems
JAK
Oct 11, 1988K882378P-7 COMPUTED TOMOGRAPHY SYSTEM
Philips Medical Systems (Cleveland), Inc.
JAK
Sep 2, 1988K881674SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
Shimadzu Precision Instruments, Inc.
JAK
Aug 19, 1988K882906DENTASCAN
Mpdi, Inc.
JAK
Aug 15, 1988K882581CT MAX 640 #B7940 JA/JE
General Electric Co.
JAK
Aug 15, 1988K882022TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM
Philips Medical Systems, Inc., NL
JAK
Jul 26, 1988K875088XENON CT
Siemens Medical Solutions USA, Inc.
JAK
May 18, 1988K875370SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
Shimadzu Precision Instruments, Inc.
JAK
Mar 28, 1988K880965SOMATOM PLUS
Siemens Medical Solutions USA, Inc.
JAK

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