Data / Medical devices / Camera, Scintillation (Gamma) / United States
FDA-registered makers of Camera, Scintillation (Gamma) in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Camera, Scintillation (Gamma) (product code IYX). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Camera, Scintillation (Gamma)
- Product code
- IYX
- Country
- United States
Makers of Camera, Scintillation (Gamma) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| CMR Naviscan Corporation | Carlsbad, CA, United States | Manufacturer | 2 | September 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Digirad Diagnostic Imaging, LLC | Poway, CA, United States | Manufacturer | 2 | January 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 1 | September 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 1 | November 24, 1993 | 0 | 0 | 0 | api.fda.gov |
| Radiopharmaceutical Imaging & Dosimetry, LLC | Baltimore, MD, United States | Manufacturer | 1 | February 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Smartbreast Corporation, Inc. | Sherman Oaks, CA, United States | Complaint file establishment, Specification developer | 1 | November 3, 2010 | 0 | 0 | 0 | api.fda.gov |
| Mim Software Inc. | Cleveland, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonomed, Inc. | Westbury, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UFP Technologies, Inc. | Compton, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.