CMR Naviscan Corporation

Carlsbad, CA, US

CMR NAVISCAN CORPORATION appears in FDA device records in Carlsbad, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to CMR Naviscan 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.

Naviscan Pet Systems510(k), recall

510(k) clearance history

FDA records hold 1 510(k) clearance for CMR Naviscan Corporation in 2008.

Clearances by year, as a table

510(k) clearance decisions for CMR Naviscan Corporation, by decision year
Year	Clearances
2008	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K082354	STEREO NAVIGATOR ACCESSORY, STN-1000	KPS	Substantially Equivalent	2008-11-18

Registered establishments

FDA registered establishments for CMR Naviscan Corporation, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3005945241	3005945241	CMR NAVISCAN CORPORATION	2720 Loker Ave W Ste O, Carlsbad, CA 92010 US	2026	IYX KPS 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-2229-2008	Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.	This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient. The investigation identified that a secondary fault protection did not perform as expected.		2008-06-19	Terminated
Z-0041-2008	PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.	Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet rema		2007-08-01	Terminated

Verification record

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