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FDA 510(k)

OUR ROTATING GAMMA SYSTEM

K-Number: K970647 · 1997-05-20

ApplicantOur Scientific Intl., Inc.
Decision Date1997-05-20
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OUR ROTATING GAMMA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Our Scientific Intl., Inc.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K970647. 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 OUR ROTATING GAMMA SYSTEM?

OUR ROTATING GAMMA SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Our Scientific Intl., Inc.. The 510(k) number is K970647.

When did OUR ROTATING GAMMA SYSTEM receive FDA 510(k) clearance?

OUR ROTATING GAMMA SYSTEM received FDA 510(k) clearance on 1997-05-20, under 510(k) number K970647.

Who is the listed applicant for OUR ROTATING GAMMA SYSTEM?

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

What is the FDA product code for OUR ROTATING GAMMA SYSTEM?

The FDA product code for OUR ROTATING GAMMA SYSTEM is IWB.

Related Clinical Trials

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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Other records listing Our Scientific Intl., 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.

K991815EXPLORER 3D

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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