# K103394: Barcode Conical Collimator Verification (BCCV)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Oncology Systems
- Decided: Jan 12, 2011 after 54 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001643 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs), Varian Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K142268: Varian Verification System (VVS) (2014), 0 descendants of its own

## Recalls of this device
- Dec 12, 2011 · Not classified · Z-0716-2012: When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, 

## Indications for use
The Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.

Source page: https://510kreport.com/device/K103394
Methodology: https://510kreport.com/methodology