Data / Medical devices / United States / CurveBeam, LLC

CurveBeam, LLC: FDA-registered device maker in Hatfield, PA, United States, 6 510(k) clearances

Name: CurveBeam, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CurveBeam, LLC is registered with the FDA (registration 3009543051) in Hatfield, PA, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009543051
Address: 2800 Bronze Dr. STE#110, Hatfield, PA, United States, 19440
Owner or operator: CurveBeam (10040447)
Roles: Manufacturer
First device listed: April 16, 2012
Registered through: 2026
Brand names listed: CubeVue, HiRise, In Reach, In Reach HR-pQCT, LineUP, PedCAT, pedCAT Premium

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 12, 2024	K241713	HiRise (1040-230)	JAK	Substantially Equivalent	Curvebeam, LLC	accessdata.fda.gov
November 18, 2020	K203187	HiRise	JAK	Substantially Equivalent	Curvebeam, LLC	accessdata.fda.gov
August 7, 2018	K181962	CubeVue	LLZ	Substantially Equivalent	Curvebeam, LLC	accessdata.fda.gov
May 11, 2018	K180727	LineUp	JAK	Substantially Equivalent	Curvebeam, LLC	accessdata.fda.gov
May 5, 2017	K170789	In Reach	JAK	Substantially Equivalent	Curvebeam, LLC	accessdata.fda.gov
April 10, 2012	K113548	PEDCAT	JAK	Substantially Equivalent	Curvebeam, LLC	accessdata.fda.gov

Compare with other makers

Updated July 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.