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FDA 510(k)

EXTEND FRAME SYSTEM, MODEL 1009633

K-Number: K092083 · 2009-09-22

ApplicantElekta Instrument AB
Decision Date2009-09-22
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXTEND FRAME SYSTEM, MODEL 1009633 is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2009-09-22 under 510(k) number K092083. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTEND FRAME SYSTEM, MODEL 1009633?

EXTEND FRAME SYSTEM, MODEL 1009633 is a medical device that received FDA 510(k) clearance on 2009-09-22. The listed applicant is Elekta Instrument AB. The 510(k) number is K092083.

When did EXTEND FRAME SYSTEM, MODEL 1009633 receive FDA 510(k) clearance?

EXTEND FRAME SYSTEM, MODEL 1009633 received FDA 510(k) clearance on 2009-09-22, under 510(k) number K092083.

Who is the listed applicant for EXTEND FRAME SYSTEM, MODEL 1009633?

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

What is the FDA product code for EXTEND FRAME SYSTEM, MODEL 1009633?

The FDA product code for EXTEND FRAME SYSTEM, MODEL 1009633 is IWB.

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Related Devices (Code: IWB)

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.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, 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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