Company Product Description Indication Status
Carestream Health Inc., of Rochester, N.Y. Dual-Energy imaging technology Uses two filter materials that switch between low- and high-energy exposures to provide corresponding bone-only and tissue-only images Chest X-ray on DRX-Evolution Plus system Received FDA clearance
Carestream Health Inc., of Rochester, N.Y. Focus 35C detector Provides diagnosis for human anatomy in adult and pediatric patients General-purpose diagnostic procedures Received FDA clearance
Carestream Health Inc., of Rochester, N.Y. Image Suite Standalone radiographic imaging software system Picture archive and communication system (PACS) Received FDA clearance
Renovia Inc. Leva Pelvic Digital Therapeutic Uses sensor and app technology to provide real-time feedback on pelvic floor muscle exercises Women with pelvic floor disorders Received 510(k) clearance
US Medical Innovations Inc. Canady Plasma Smart XL-1000 electrosurgical generator Electrosurgical generator For cutting, coagulating and other surgical intervention modes Received 510(k) clearance

Notes

For more information about individual companies and/or products, see Cortellis.

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