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Spectrawave, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2025-12-15
TypeNumberDevice NameCodeDateActions
510(k) K253101 HyperVue™ Imaging System - IntegratedNQQ2025-12-15 View
510(k) K251355 X1-FFRQHA2025-10-17 View
510(k) K251198 HyperVue™ SoftwareNQQ2025-07-16 View
510(k) K243016 Starlight Imaging CatheterNQQ2025-03-20 View
510(k) K230691 HyperVue™ Imaging SystemNQQ2023-06-07 View
510(k) K221257 SpectraWAVE Imaging SystemNQQ2023-02-28 View
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