510(k) Report

Devices descending from K061685

15 later devices reach Pulsera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090590Veradius, Model 718-130Philips Medical Systems North America Co.200914—
+2K133819VeradiusPhilips Medical Systems Nederland B.V.201412—
+2K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+3K142708Veradius UnityPhilips Medical Systems Nethrlands BV2014114
+4K250010Extron 3; Extron 5; Extron 7DRTECH Corporation20251—
+4K230871Extron 5; Extron 7DRTECH Corporation20233—
+4K183040Zenition 70Philips Medical Systems Nederland B.V.201865
+5K261413Extron 3;Extron 6DRTECH Corporation20260—
+5K251893Skan C PulsarSkanray Technologies Limited20250—
+5K222080Garion Image-Intensified Fluoroscopic X-Ray System, MobileSg Healthcare Co, Ltd.20221—
+5K212813Zenition 70Philips Medical Systems Nederland B.V.202134
+6K243411Diagnostic X-ray SystemNanjing Perlove Medical Equipment Co., Ltd.20250—
+6K240224Zenition 90Philips Medical Systems Nederlands B.V.20240—
+6K232420Zenition 30Philips Medical Systems Nederland B.V.20241—
+7K254205Zenition 30Philips Medical Systems Nederland B.V.20260—