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FDA 510(k)

ROTATING GAMMA SYSTEM. GAMMA ART-6000

K-Number: K060314 · 2006-04-06

ApplicantAmerican Radiosurgery, Inc.
Decision Date2006-04-06
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROTATING GAMMA SYSTEM. GAMMA ART-6000 is the device name listed in this FDA 510(k) record. The listed applicant is American Radiosurgery, Inc.. It received FDA 510(k) clearance on 2006-04-06 under 510(k) number K060314. 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 ROTATING GAMMA SYSTEM. GAMMA ART-6000?

ROTATING GAMMA SYSTEM. GAMMA ART-6000 is a medical device that received FDA 510(k) clearance on 2006-04-06. The listed applicant is American Radiosurgery, Inc.. The 510(k) number is K060314.

When did ROTATING GAMMA SYSTEM. GAMMA ART-6000 receive FDA 510(k) clearance?

ROTATING GAMMA SYSTEM. GAMMA ART-6000 received FDA 510(k) clearance on 2006-04-06, under 510(k) number K060314.

Who is the listed applicant for ROTATING GAMMA SYSTEM. GAMMA ART-6000?

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

What is the FDA product code for ROTATING GAMMA SYSTEM. GAMMA ART-6000?

The FDA product code for ROTATING GAMMA SYSTEM. GAMMA ART-6000 is IWB.

Related Clinical Trials

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Other records listing American Radiosurgery, Inc. 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.

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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

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

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