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FDA 510(k)

DPD-510 THERAPEUTIC RADIATION DOSIMETER

K-Number: K925133 · 1993-01-04

ApplicantScanditronix, Inc.
Decision Date1993-01-04
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DPD-510 THERAPEUTIC RADIATION DOSIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix, Inc.. It received FDA 510(k) clearance on 1993-01-04 under 510(k) number K925133. 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 DPD-510 THERAPEUTIC RADIATION DOSIMETER?

DPD-510 THERAPEUTIC RADIATION DOSIMETER is a medical device that received FDA 510(k) clearance on 1993-01-04. The listed applicant is Scanditronix, Inc.. The 510(k) number is K925133.

When did DPD-510 THERAPEUTIC RADIATION DOSIMETER receive FDA 510(k) clearance?

DPD-510 THERAPEUTIC RADIATION DOSIMETER received FDA 510(k) clearance on 1993-01-04, under 510(k) number K925133.

Who is the listed applicant for DPD-510 THERAPEUTIC RADIATION DOSIMETER?

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

What is the FDA product code for DPD-510 THERAPEUTIC RADIATION DOSIMETER?

The FDA product code for DPD-510 THERAPEUTIC RADIATION DOSIMETER is IWB.

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Other records listing Scanditronix, 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.

K934303RFA A-300K942092DPD-3K914926SCANDIPLAN - VERSION 338K904753DIOLASEK900434MM-22 MICROTRON, MM50 MICROTRONK843366SUPERPETT

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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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