# K101042: Bladeview

- Pathway: 510(k) (Traditional)
- Applicant: Accogent, LLC
- Decided: Oct 29, 2010 after 198 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083224: Cpi Rad Vision, Model VZW2944XX-YY, Communications & Power Industries Canada, Inc. (2009) Summary page 1.
- K081073: HDR Vision, Vision HDR, HD R/F, Uromat HD R/F, Pausch, LLC (2008) Summary page 1.

## Indications for use
The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. it is intended to replace conventional film screen systems, The BladeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. The BladeView enables a qualified operator to acquire, process, and display images. The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications.

Source page: https://510kreport.com/device/K101042
Methodology: https://510kreport.com/methodology