Atlas FDA

CARESTREAM PACS

FDA 510(k) clearance K110919 · decided 2011-10-20

Clearance details

K-number
K110919
Device name
CARESTREAM PACS
Applicant
Carestream Health, Inc.
Decision
Substantially Equivalent
Date received
2011-04-01
Decision date
2011-10-20
Days to decision
202 days
Clearance type
Traditional
Product code
LLZ
Device class
2
Regulation number
892.2050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number recall (Z-0497-2025)Philips Medical Systems Technologies Ltd.2024-11-20
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image ma recall (Z-0211-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image man recall (Z-0212-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an ima recall (Z-0213-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image recall (Z-0214-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an imag recall (Z-0215-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image m recall (Z-0216-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image m recall (Z-0217-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image m recall (Z-0218-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image mana recall (Z-0219-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an ima recall (Z-0220-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image m recall (Z-0221-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image mana recall (Z-0222-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image manag recall (Z-0223-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image m recall (Z-0224-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image m recall (Z-0225-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image man recall (Z-0226-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image man recall (Z-0227-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image m recall (Z-0228-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image m recall (Z-0229-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image m recall (Z-0230-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image manage recall (Z-0231-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image mana recall (Z-0232-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image man recall (Z-0233-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image recall (Z-0234-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image m recall (Z-0235-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image m recall (Z-0236-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image m recall (Z-0237-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image m recall (Z-0238-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image m recall (Z-0239-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image man recall (Z-0240-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0241-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0242-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0243-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0244-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0245-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0246-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image m recall (Z-0248-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image m recall (Z-0249-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image m recall (Z-0250-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image ma recall (Z-0251-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image ma recall (Z-0252-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image m recall (Z-0253-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image m recall (Z-0254-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image m recall (Z-0255-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image m recall (Z-0256-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0257-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0258-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0259-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0260-2014)Carestream Health Inc.2013-11-13

PMA approvals by this applicant

RecordFirmDate
KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE (P080018/S001)Carestream Health, Inc.2010-12-01
KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY (P080018)Carestream Health, Inc.2010-11-03
KODAK MAMMOGRAPHY CAD ENGINE (P030007/S003)Carestream Health, Inc.2007-03-23
MAMMOGRAPHY CAD ENGINE (P030007/S001)Carestream Health, Inc.2005-09-16
KODAK MAMMOGRAPHY CAD ENGINE (P030007)Carestream Health, Inc.2004-11-23