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FDA 510(k)

THERATRON ELITE

K-Number: K983917 · 1998-12-04

ApplicantTheratronics, Inc.
Decision Date1998-12-04
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERATRON ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Theratronics, Inc.. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K983917. 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 ELITE?

THERATRON ELITE is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Theratronics, Inc.. The 510(k) number is K983917.

When did THERATRON ELITE receive FDA 510(k) clearance?

THERATRON ELITE received FDA 510(k) clearance on 1998-12-04, under 510(k) number K983917.

Who is the listed applicant for THERATRON ELITE?

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 ELITE?

The FDA product code for THERATRON ELITE 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.

K970236THERAPLAN PLUS VERSION 1.2K964606THERATRON 780EK964607THERATON 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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