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FDA 510(k)

CLARITY OBP SYSTEM

K-Number: K111332 · 2012-01-30

ApplicantElekta , Ltd.
Decision Date2012-01-30
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLARITY OBP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elekta , Ltd.. It received FDA 510(k) clearance on 2012-01-30 under 510(k) number K111332. 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 CLARITY OBP SYSTEM?

CLARITY OBP SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-30. The listed applicant is Elekta , Ltd.. The 510(k) number is K111332.

When did CLARITY OBP SYSTEM receive FDA 510(k) clearance?

CLARITY OBP SYSTEM received FDA 510(k) clearance on 2012-01-30, under 510(k) number K111332.

Who is the listed applicant for CLARITY OBP SYSTEM?

The FDA 510(k) record lists Elekta , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARITY OBP SYSTEM?

The FDA product code for CLARITY OBP SYSTEM is IYE.

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Other records listing Elekta , 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.

K123808AGILITYK121663CLARITYK121328AGILITYK102200INTEGRITY MODEL 1014284K100115XVI R4.5K082122MLCI2

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Related Devices (Code: IYE)

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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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