System, Tomography, Computed, Emission
Regulation 892.1200
9510(k)s in 12 months (473 all time)
9recalls in 12 months (450 all time)
435recalls that name a 510(k)
Top companies in KPS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2011 | Philips Medical Systems Precedence System;
SYST,PRECEDENCE, 16 SLICE 3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produc Terminated |
KPS | K041218 |
| Nov 19, 2011 | Philips Medical Systems Precedence System;
SYST,PRECEDENCE, 16 SLICE 5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produc Terminated |
KPS | K041218 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,9FT,5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,9FT,3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,8FT,5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,8FT,3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT, 5/8",SPECT;
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to prod Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT, 3/8",SPECT;
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to prod Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT 8FT, 5/8" SPECT
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to Terminated |
KPS | K000908 |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT 8FT, 3/8" SPECT
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to Terminated |
KPS | K000908 |
| Sep 13, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system unit Terminated |
KPS | K081135 |
| Aug 10, 2011 | Siemens Medical Solutions USA, Inc. Symbia Radiation Therapy Pallet.
Siemens Medical Solutions USA, Inc.
An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet i Terminated |
KPS | K082506 |
| Aug 4, 2011 | Philips Medical Systems BrightView XCT Gamma Camera, 3/4".
Philips Medical Systems, Inc.
Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for in Terminated |
KPS | K080927 |
| Aug 4, 2011 | Philips Medical Systems BrightView XCT Gamma Camera, 3/8".
Philips Medical Systems, Inc.
Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for in Terminated |
KPS | K080927 |
| Aug 4, 2011 | Philips Medical Systems BrightView X Gamma Camera, 3/8".
Philips Medical Systems, Inc.
Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for inte Terminated |
KPS | K062298 |
| Aug 1, 2011 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023.
The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combi Terminated |
KPS | K081135 |
| Aug 1, 2011 | Philips Medical Systems (Cleveland) Inc Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817.
Product Usag: The MX 800 Terminated |
KPS | K010817 |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Clevelan Terminated |
KPS | K062298 |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Cleveland, O Terminated |
KPS | K062298 |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Clevelan Terminated |
KPS | K062298 |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Cleveland, O Terminated |
KPS | K062298 |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Clevela Terminated |
KPS | K062298 |
| May 9, 2011 | Philips Medical Systems Brightview XCT, 3/4"
Philips Medical Systems
Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat pane Terminated |
KPS | K080927 |
| May 9, 2011 | Philips Medical Systems Brightview XCT, 3/8"
Philips Medical Systems
Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat pane Terminated |
KPS | K080927 |
| Mar 24, 2011 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269.
The Extended Brilliance Workplace (EBW) is a component o Terminated |
KPS | K012009 |
| Mar 16, 2011 | Philips Medical Systems (Cleveland) Inc Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brillianc Terminated |
KPS | K012009 K033326 +2 |
| Mar 4, 2011 | Philips Medical Systems SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8".
Philips Medical Systems
Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisot Terminated |
KPS | K000908 |
| Mar 4, 2011 | Philips Medical Systems SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT.
Philips Medical Systems
Intended to produce images depicting the anatomical distribution of single photon and positr Terminated |
KPS | K000908 |
| Nov 17, 2010 | Philips Medical Systems SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Sys Terminated |
KPS | K000908 |
| Dec 29, 2009 | Siemens Medical Solutions USA, Inc. Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061.
Indications for use: SPECT + CT: Perform scans and nucle Terminated |
KPS | K041166 |
| Nov 10, 2009 | Siemens Medical Solutions USA Inc. Siemens Biograph mCT-S 64, model number 10248672.
Medical Imaging Equipment. Terminated |
KPS | K060631 |
| Nov 10, 2009 | Siemens Medical Solutions USA Inc. Siemens Biograph mCT-S 40, model number 10248671.
Medical Imaging Equipment. Terminated |
KPS | K060631 |
| Nov 10, 2009 | Siemens Medical Solutions USA Inc. Siemens Biograph mCt-X, model number 10248670.
Medical Imaging Equipment. Terminated |
KPS | K060631 |
| Sep 17, 2009 | GE Medical Systems, LLC GE Healthcare Ventri, GE Healthcare, Waukesha, WI.
Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT.
The intended use of the VENTRi system is to perform nuclear imaging procedures for detection an Terminated |
KPS | K051855 |
| Sep 16, 2009 | Phillips Nuclear Medicine BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, Terminated |
KPS | K062298 |
| Aug 4, 2009 | Siemens Medical Solutions USA, Inc. Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061
Indications for use: SPECT + Terminated |
KPS | K041166 |
| Aug 4, 2009 | Siemens Medical Solutions USA, Inc. Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061
Indications for use: SPECT + CT: Perform scans and nucle Terminated |
KPS | K041166 |
| Jul 7, 2009 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Terminated |
KPS | K041166 |
| Jul 7, 2009 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741. Terminated |
KPS | K041166 |
| Jul 6, 2009 | Philips Medical Systems (Cleveland) Inc TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2 Terminated |
KPS | K052640 |
| Jul 6, 2009 | Philips Medical Systems (Cleveland) Inc TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as Terminated |
KPS | K051170 |
| Jul 6, 2009 | Philips Medical Systems (Cleveland) Inc Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM).
The "Extended Brilliance Wor Terminated |
KPS | K012009 |
| Jun 24, 2009 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 Terminated |
KPS | K952109 |
| Apr 21, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD.
Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer u Terminated |
KPS | K022960 |
| Apr 21, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS.
Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope trac Terminated |
KPS | K022960 |
| Apr 21, 2009 | GE Medical Systems, LLC GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM001473, ASM001620, ASM500016, H3000WM, H3000WT, H3000WY and SYS000041.
Product is used to perform general Nuclear Terminated |
KPS | K022960 |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye(R) 4, Model numbers:
H3000WC
H3000WD
Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient bo Terminated |
KPS | K022960 |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye(R), Model numbers:
H2508PY
H3000WN
H3000WR
H3000WW
H3000WY
H3000WZ
H3000YM
H3000YS
Intended use: To perform general Nuclear Medicine imaging procedures for dete Terminated |
KPS | K022960 |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060,
H3000WC and H3000WD.
The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tr Terminated |
KPS | K022960 |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS.
The device is used to perform general Nuclear Medicine imaging procedures for detection of radioi Terminated |
KPS | K022960 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.