Navigator

FDA 510(k) K042875 · Nomos Corp.

Substantially Equivalent

510(k) numberK042875

Submission

Device name
Navigator
Applicant
Nomos Corp.
Cranberry Township, PA, US
Received
October 18, 2004
Decision date
July 1, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

Other 510(k)s with product code IYE

510(k)DeviceApplicantDecision
K261718EZFluence (RADEZ V2)IYE · Traditional Radformation, Inc.08/31/2026SE
K260733MRIA Radiation Therapy Information System (MRIA)IYE · Traditional Manteia Technologies Co., Ltd.08/26/2026SE
K261856Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional Varian Medical Systems, Inc.08/03/2026SE
K252937ThinkQA 3IYE · Traditional Dosisoft SA06/12/2026SE
K253004Luna 3DIYE · Traditional Lap GmbH Laser Applikationen06/04/2026SE
K260792AerFrame Patient Immobilization System (AFPIS)IYE · Traditional Stabilix, LLC05/08/2026SE
K252258Veriqa RT Epid 3DIYE · Traditional Ptw-Freiburg Physikalisch-Technische-Werkstaetten…04/15/2026SE
K253962ClearCheck (RADCC V2.7)IYE · Traditional Radformation, Inc.04/03/2026SE
K253012AlignRT Plus (8.0)IYE · Traditional Vision Rt, Ltd.03/18/2026SE
K252977Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional Varian Medical Systems, Inc.01/21/2026SE

More from Varian Medical Systems, Inc.

510(k)DeviceDecision
K070611Bat Ultrasound Localization and Positioning System, Version 6IYE · Traditional 07/11/2007SE
K060895Nomosstat, Version 1.0IYE · Special 07/21/2006SE
K032209Nomos Corvus 5.0MMUJ · Special 08/21/2003SE
K013036Nomos Motorized Crane IIJAI · Traditional 12/07/2001SE
K993675Peregrine Radiation Therapy Dose Calculation SystemMUJ · Traditional 09/05/2000SE
K993359Raptor Treatment Planning SystemIYE · Traditional 12/21/1999SE
K991966The Nomos Chane IIIYE · Traditional 09/03/1999SE
K981424Nomos Bat Ultrasound Localization and Positioning SystemIYE · Traditional 07/17/1998SE
K974310Nomos Slit Collimator (Beak)IYE · Traditional 02/06/1998SE
K972451Coregistration FunctionIYE · Traditional 01/22/1998SE

Questions and answers

When was Navigator cleared by the FDA?

Navigator (K042875) received a 510(k) decision of Substantially Equivalent on July 1, 2005, 256 days after the submission was received.

What is the product code of K042875?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.