Data / Medical devices / United States / Nova Medical, Inc

Nova Medical, Inc: FDA-registered device maker in Wilmington, MA, United States, 2 510(k) clearances

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

Nova Medical, Inc is registered with the FDA (registration 3004531751) in Wilmington, MA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 15, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004531751
Address: 150 West ST Ste 201, Wilmington, MA, United States, 01887
Owner or operator: Nova Medical Inc. (10054509)
Roles: Contract manufacturer, Manufacturer
First device listed: November 9, 2017
Registered through: 2026
Brand names listed: 1Tx32Rx Head Coil 7T Clinic, 2Tx32Rx 7T Head Coil for GE, 3T 32 Channel Head Coil for GE, 3T 32 Channel Head Coil for GE MR750, 8Tx32Rx Head Coil 7T Clinic for Siemens

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	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
October 15, 2020	K201615	SIGNA 7.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 12, 2019	K182737	3T 32 Channel Head Coil	MOS	Substantially Equivalent	Nova Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 15, 2020. 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.