# K091631: Accessnet, Accessmed, Accessrad, Medview

- Pathway: 510(k) (Traditional)
- Applicant: Aspyra, Inc.
- Decided: Mar 18, 2010 after 288 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K942120 (1994). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973805: Imageaccess System, Storcomm, Inc. (1998) Summary page 2.
- K003438: Smart Rad, Cmt Medical Technologies, Ltd. (2001) Summary page 2.
- K013218: Fuji Speed Suite, Fuji Speed Sute Phase II, Fujifilm Medical System U.S.A., Inc. (2001) Summary page 2.
- K041990: Fuji Medical CR Console, Model Flash Iip, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 2.
- K051553: Fuji Synapse Workstation Software, Fujifilm Medical Systems U.S.A, Inc. (2005) Summary page 2.
- K082318: Centricity Pacs IW, Ge Healthcare Dynamic Imaging Solutions (2008) Summary page 2.

## Indications for use
The Aspyra AccessNET PACS is a software device designed to operate on specified off-the-shelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and data can be captured, stored, communicated, processed, printed, and displayed within the system and or across computer networks at distributed locations. Display and processing functions while viewing images include, but are not limited to, adjustment of window and level, rotatidn, zoom, measurement of anatomical structures, image stitching, image stacking, filtration of color images (e.g. removal of red channel), annotation and measurement of regions of interest, inversion, rotation, flips, Multi-Planar Reformation (MPR), and Maximum intensity projection (MIP). In addition, users can dictate, edit, sign, and print reports. The Aspyra. AccessNET PACS is indicated for the primary review of "For Presentation" DICOM mamnmographic images. Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations. Mammographic images for primary image interpretations may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K091631
Methodology: https://510kreport.com/methodology