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FDA 510(k)

THERATRON 780E

K-Number: K964606 · 1997-06-26

ApplicantTheratronics, Inc.
Decision Date1997-06-26
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERATRON 780E is the device name listed in this FDA 510(k) record. The listed applicant is Theratronics, Inc.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K964606. 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 THERATRON 780E?

THERATRON 780E is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is Theratronics, Inc.. The 510(k) number is K964606.

When did THERATRON 780E receive FDA 510(k) clearance?

THERATRON 780E received FDA 510(k) clearance on 1997-06-26, under 510(k) number K964606.

Who is the listed applicant for THERATRON 780E?

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

What is the FDA product code for THERATRON 780E?

The FDA product code for THERATRON 780E is IWB.

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Other records listing Theratronics, 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.

K983917THERATRON ELITEK970236THERAPLAN PLUS VERSION 1.2K964607THERATON 1000EK954679THERAPLAN PLUSK940237THERAPLAN V05B/ TP-11 V09BK922276THERAC 25

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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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