Innovatus Imaging Corporation

Englewood, CO, US

Innovatus Imaging Corporation appears in FDA device records in Englewood, CO. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Innovatus Imaging Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Soma Access Systems, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Innovatus Imaging Corporation in 2011.

Clearances by year, as a table

510(k) clearance decisions for Innovatus Imaging Corporation, by decision year
Year	Clearances
2011	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K113680	SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT	IYO	Substantially Equivalent	2011-12-29

Registered establishments

FDA registered establishments for Innovatus Imaging Corporation, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3009436116	3009436116	Innovatus Imaging Corporation	357 Inverness Dr. South, Suite C, Englewood, CO 80112 US	2026	ITX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0215-2015	AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.	There is a possibility the sterile packaging may fail before the expiration date specified on the package.	Class II	2014-03-24	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain