# K091558: Biovision Digital Specimen Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Bioptics, Inc.
- Decided: Jul 17, 2009 after 50 days
- Product code: MWP (Cabinet, X-Ray System)
- 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: 2 generations back to K021113 (2002). 2 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052433: Pixarray 100 Digital Specimen Radiography (DSR) System, Bioptics, Inc. (2005) Summary page 1.

## Most influential descendants
- K122428: Faxitron Specien Radiography System (2012), 4 descendants of its own
- K153583: BioVision Plus (2016), 3 descendants of its own
- K170786: Faxitron Bioptics Speciemen Radiography System (2017), 2 descendants of its own
- K173309: Faxitron VisionCT (2018), 1 descendant of its own
- K213691: Solas OR (2021), 0 descendants of its own

## Indications for use
The BioVision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has beeh excised during excisional or percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.

Source page: https://510kreport.com/device/K091558
Methodology: https://510kreport.com/methodology