Cuattro Imaging, LLC

Avon, CO, US

CUATTRO IMAGING, LLC appears in FDA device records in Avon, CO. FDA records list 2 510(k) clearances between 2010-03-05 and 2016-10-06, 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: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Cuattro Imaging, LLC 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.

Cuattro, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Cuattro Imaging, LLC between 2010 and 2016. The busiest year on record is 2010, with 1. The most recent is 2016, with 1.

Clearances by year, as a table

510(k) clearance decisions for Cuattro Imaging, LLC, by decision year
Year	Clearances
2010	1
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K161937	CuattroDR	KPR	Substantially Equivalent	2016-10-06
K093480	CUATTRO UNOMD	LLZ	Substantially Equivalent	2010-03-05

Registered establishments

FDA registered establishments for Cuattro Imaging, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008364043	3008364043	CUATTRO IMAGING, LLC	910 Nottingham Ranch Rd Ste N-11, Avon, CO 81620 US	2026	KPR LLZ

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-1934-2020	CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0	There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.	Class II	2019-10-15	Terminated

Verification record

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