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510(k) Data Aggregation
K Number
K241425Device Name
AspenView
Manufacturer
Date Cleared
2025-02-12
(268 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Aspen Imaging Healthcare Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). The main features of this software are storing acquired images, data management, image processing and image stitching.
Device Description
AspenView software is designed for use by radiologists and radiology technicians for annotation in the X-ray images. The AspenView software is developed to use Aspen Imaging Flat Panel DR Detector and Aspen Imaging Healthcare Inc Image Viewer. The purpose of AspenView software is for the doctor to annotate X-ray images and then to print out with patient information or sent to another PACS system.
A client user needs to install AspenView first in the recommended PC environment. After installation, the client user chooses a DICOM format in the uploaded patient list to be annotated, and then annotation is written by user after reviewing of image chosen. After annotation has completed it can be printed out, saved or sent to another PACS system.
AspenView software includes an image stitching function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission.
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K Number
K241346Device Name
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
Manufacturer
Date Cleared
2024-11-07
(178 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Aspen Imaging Healthcare Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography.
Device Description
The IODR1717 / IODR1417 / IODR1417-GF detectors are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The IODR1717 / IODR1417 / IODR1417-GF detectors utilize a combination of propriety TFT and scintillator (Csl), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration.
The flat panel sensors of The IODR1717 / IODR1417 / IODR1417-GF are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well matched to scintillators such as Csl. The response has the excellent linearity of a charge-integrating-biased photodiode.
Aspen\View software includes the basic functionality: generator control, detector control, firmware, image acquisition, image calibration and correction, image storage.
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