510(k) Report

Devices descending from K051022

10 later devices reach Gammaplan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090972Leksell GammaplanElekta Instrument AB20096—
+1K061540Leksell GammaplanElekta Instrument AB20069—
+2K103093Leksell GammaplanElekta Instrument AB201051
+2K091602Mucheck V8Oncology Data Systems, Inc.20091—
+3K151666Leksell GammaPlanElekta Instrument AB201541
+3K102583Mucheck, Version 9.0Oncology Data Systems, Inc.20100—
+4K173791Leksell GammaPlanElekta Instrument AB201832
+5K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+5K193459Panther StereotacticProwess, Inc.20201—
+6K231825Panther TPSProwess, Inc.20230—