Search Results
Found 3 results
510(k) Data Aggregation
K Number
K122260Device Name
AYCAN MOBILE
Manufacturer
AYCAN DIGITALSYSTEME GMBH
Date Cleared
2012-09-12
(47 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AYCAN DIGITALSYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.
aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Device Description
aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.
Ask a Question
K Number
K103546Device Name
AYCAN WORKSTATION OSIRIX PRO
Manufacturer
AYCAN DIGITALSYSTEME GMBH
Date Cleared
2011-03-17
(105 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AYCAN DIGITALSYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
aycan workstation OsiriX PRO is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware.
Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Device Description
The aycan workstation OsinX PRO provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. aycan workstation OsiriX PRO runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images.
aycan workstation OsiriX PRO is a software device that handles and manipulates digital medical images.
Ask a Question
K Number
K063470Device Name
AYCAN WORKSTATION OSIRIX
Manufacturer
AYCAN DIGITALSYSTEME GMBH
Date Cleared
2007-01-05
(50 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AYCAN DIGITALSYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
aycan Workstation OsiriX is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware.
Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Device Description
The aycan Workstation OsiriX provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. aycan workstation OsiriX runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images.
Ask a Question
Page 1 of 1