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FDA 510(k)

.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR

K-Number: K040804 · 2004-04-28

ApplicantSoutheastern Radiation Products, Inc.
Decision Date2004-04-28
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Southeastern Radiation Products, Inc.. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K040804. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR?

.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Southeastern Radiation Products, Inc.. The 510(k) number is K040804.

When did .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR receive FDA 510(k) clearance?

.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR received FDA 510(k) clearance on 2004-04-28, under 510(k) number K040804.

Who is the listed applicant for .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR?

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

What is the FDA product code for .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR?

The FDA product code for .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR is IXI.

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 Southeastern Radiation Products, 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.

K023636BLOCKING TRAY

Related Devices (Code: IXI)

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.

K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLCK222639VHA Radiotherapy BolusVha DeanK214093VSP Bolus3D SystemsK132236.DECIMAL PROTON APERTURE.Decimal, Inc.K131150CURA COMPENSATORCura Medical Technologies, LLCK123893CURA COLLIMATORCura Medical Technologies, LLC

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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