ClearanceBrief
Panels › Radiology › Product code KPR · Class 2

System, X-Ray, Stationary

Regulation 892.1680

7510(k)s in 12 months (359 all time)
3recalls in 12 months (170 all time)
160recalls that name a 510(k)
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Top companies in KPR

DateFirm and productCodeLinked 510(k)
Jun 30, 2007Carestream Health, Inc.
Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.
Terminated
KPRK051258
Feb 14, 2006General Electric Med Systems LLC
Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power
Terminated
KPRK993090
Jan 6, 2006AGFA Corp.
ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
Terminated
KPRK974597
Dec 8, 2005Eastman Kodak Co
KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top;
Terminated
KPRK001341
Nov 24, 2005Analogic Corporation
Analogic SyneRad Multi Digital Radiology System, Model AN6150
Terminated
KPRK040995
Nov 8, 2005Philips Ultrasound, Inc.
Optimus 30
Terminated
KPRK945278
Jul 13, 2005Siemens Medical Solutions USA, Inc
Axiom Aristos FX. Model number 74 14 803
Terminated
KPRK013826
Jul 13, 2005Siemens Medical Solutions USA, Inc
Axiom Aristos MX/VX. Model number 58 95 003
Terminated
KPRK013826
Jul 13, 2005Siemens Medical Solutions USA, Inc
Axiom Aristos TX. Model number 58 94 873 Radiology system
Terminated
KPRK013826
Dec 24, 2004Philips Medical Systems Sales & Service Region No. America
Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
Terminated
KPRNone listed
Dec 24, 2004Philips Medical Systems Sales & Service Region No. America
Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
Terminated
KPRK931071
K981657
Aug 4, 2004Philips Medical Systems Sales & Service Region No. America
EasyDiagnost Eleva Part Number 989605071921
Terminated
KPRNone listed
Jul 20, 2004Eastman Kodak Co
Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ce
Terminated
KPRK001341
Dec 24, 2003Philips Medical Systems Sales & Service Region No. America
Philips Digital Diagnost VT
Terminated
KPRNone listed
Dec 24, 2003Philips Medical Systems Sales & Service Region No. America
Digital Diagnost VE
Terminated
KPRNone listed
Dec 24, 2003Philips Medical Systems Sales & Service Region No. America
Bucky Diagnost FS Part number 9890-010-83651
Terminated
KPRK945278
Dec 19, 2003Health Care Manufacturing Inc
HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
Terminated
KPRK022737
Jul 8, 2003Siemens Medical Solutions USA, Inc
Axiom Aristos X-Ray System.
Terminated
KPRK013826
Apr 25, 2003Sedecal USA, Inc.
Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Terminated
KPRK012546
Mar 5, 2003X-Cel X-Ray Corp
X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012
Terminated
KPRNone listed

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