DOSEOPTICS LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3019552217	3019552217	DOSEOPTICS LLC	1	N	2026-01-01	16 Cavendish Ct Lebanon NH US 03766

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
313822	1644042195	K233622	AlignRT Plus	IYE	2024-03-29
313822	1898699532	K212606	BeamSite	IYE	2021-09-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
IYE	2	2024-03-29

PMN#

BeamSite
2021-09-15
DoseOptics LLC
BeamSite
2020-12-11
DoseOptics LLC

GUDID#

BeamSite - 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.
Doseoptics LLC
2023-08-10