AccessGUDID - DEVICE: BeamSite (00860009184503)

GUDID

Device Identifier (DI) Information

Brand Name: BeamSite
Version or Model: BeamSite
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Doseoptics LLC

Primary DI Number: 00860009184503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079605332 *Terms of Use

Device Description: BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient’s skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40887	Radiation therapy software	An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.	Active	false
40942	Radiation therapy system workstation, multi-purpose	A freestanding, multi-purpose, image processing device that can be a component of one or more radiation therapy systems, e.g., teletherapy, brachytherapy or linear accelerator. It is sometimes considered to be a component of a picture archiving and communication system (PACS) or a local area network (LAN) configuration, e.g., a radiology information system (RIS) or hospital information system (HIS). It does not contain the controls for the direct operation of the radiation therapy system. It can receive and transmit data both on-line and off-line and is configured to provide the capability to remotely process, manipulate and view patient images/information used in patient treatment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212606	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd9ab582-3372-4f8e-a772-7ff0ee63468f
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023