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FDA 510(k)

MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM

K-Number: K031980 · 2003-07-25

ApplicantElekta Instrument AB
Decision Date2003-07-25
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM 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 2003-07-25 under 510(k) number K031980. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM?

MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Elekta Instrument AB. The 510(k) number is K031980.

When did MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031980.

Who is the listed applicant for MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM?

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 MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM?

The FDA product code for MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM is HAW.

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Other records listing Elekta Instrument 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.

K190887Leksell Vantage Stereotactic SystemK173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconK173791Leksell GammaPlanK171123Leksell Vantage Stereotactic SystemK160440Leksell Gamma Knife IconK152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit

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Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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