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The Sentinel Imaging Group, Inc: FDA-registered device maker in Clarks Summit, PA, United States, 1 510(k) clearance

Name: The Sentinel Imaging Group, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Sentinel Imaging Group, Inc is registered with the FDA (registration 3012081348) in Clarks Summit, PA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012081348
Address: 1172 Winola Rd, Clarks Summit, PA, United States, 18411
Owner or operator: The Sentinel Imaging Group, INC (10049984)
Roles: Repackager or relabeler
First device listed: August 15, 2017
Registered through: 2026
Brand names listed: BK Medical Transducer

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	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
February 13, 2013	K123254	ULTRASOUND SCANNER FLEX FOCUS	IYN	Substantially Equivalent	B-K Medical Aps	accessdata.fda.gov

Compare with other makers

Updated February 13, 2013. 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.