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FDA 510(k)

Klarity Bolus

K-Number: K202747 · 2021-05-14

ApplicantKlarity Medical & Equipment (GZ) Co., Ltd.
Decision Date2021-05-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Klarity Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K202747. 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 Klarity Bolus?

Klarity Bolus is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. The 510(k) number is K202747.

When did Klarity Bolus receive FDA 510(k) clearance?

Klarity Bolus received FDA 510(k) clearance on 2021-05-14, under 510(k) number K202747.

Who is the listed applicant for Klarity Bolus?

The FDA 510(k) record lists Klarity Medical & Equipment (GZ) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klarity Bolus?

The FDA product code for Klarity Bolus is IYE.

Other records listing Klarity Medical & Equipment (GZ) Co., Ltd. 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.

K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)K220539Klarity SRS Baseplate, Klarity Promise Baseplate

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (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.

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