Data / Medical devices / United States / CMR Naviscan Corporation
CMR Naviscan Corporation: FDA-registered device maker in Carlsbad, CA, United States, 6 510(k) clearances
CMR Naviscan Corporation is registered with the FDA (registration 3005945241) in Carlsbad, CA, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 23, 2011. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005945241
- Address
- 2720 Loker Ave W Ste O, Carlsbad, CA, United States, 92010
- Owner or operator
- CMR Naviscan Corporation (10045732)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 20, 2013
- Registered through
- 2026
- Brand names listed
- LumaGEM MBI Software, LumaGEM Molecular Breast Imaging (MBI) System, LumaGEM Scintillation Camera
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| September 23, 2011 | K111791 | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM | IYX | Substantially Equivalent | Gamma Medica-Ideas Incorporated | accessdata.fda.gov |
| September 15, 2011 | K111731 | MOLECULAR BREAST IMAGING SOFTWARE | LLZ | Substantially Equivalent | Gamma Medica-Ideas Incorporated | accessdata.fda.gov |
| March 31, 2009 | K090553 | NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER | KPS | Substantially Equivalent | Naviscan, Inc. | accessdata.fda.gov |
| November 18, 2008 | K082354 | STEREO NAVIGATOR ACCESSORY, STN-1000 | KPS | Substantially Equivalent | Naviscan Pet Systems | accessdata.fda.gov |
| August 18, 2003 | K032063 | PEM 2400 PET SCANNER | KPS | Substantially Equivalent | Pem Technologies | accessdata.fda.gov |
| January 18, 2000 | K993813 | LUMAGEM SCINTILLATION CAMERA | IYX | Substantially Equivalent | Gamma Medica | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 19, 2008 | 48694 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| August 1, 2007 | 44791 | Not yet classified | Terminated | 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, measurem | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Camera, Scintillation (Gamma)
- All makers of System, Tomography, Computed, Emission
Updated September 23, 2011. 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.