FDA 510(k)

Sentinel

K-Number: K200600 · 2020-04-20

Decision Date2020-04-20

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Sentinel is the device name listed in this FDA 510(k) record. The listed applicant is C-Rad Positioning AB. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K200600. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentinel?

Sentinel is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is C-Rad Positioning AB. The 510(k) number is K200600.

When did Sentinel receive FDA 510(k) clearance?

Sentinel received FDA 510(k) clearance on 2020-04-20, under 510(k) number K200600.

Who is the listed applicant for Sentinel?

The FDA 510(k) record lists C-Rad Positioning AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentinel?

The FDA product code for Sentinel is IYE.

Other records listing C-Rad Positioning AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200435Catalyst+, Catalyst+ HD

Related Devices (Code: IYE)

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen K260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC K252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla K253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.