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FDA 510(k)

.DECIMAL PROTON APERTURE

K-Number: K132236 · 2013-10-16

Applicant.Decimal, Inc.
Decision Date2013-10-16
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

.DECIMAL PROTON APERTURE is the device name listed in this FDA 510(k) record. The listed applicant is .Decimal, Inc.. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K132236. 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 PROTON APERTURE?

.DECIMAL PROTON APERTURE is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is .Decimal, Inc.. The 510(k) number is K132236.

When did .DECIMAL PROTON APERTURE receive FDA 510(k) clearance?

.DECIMAL PROTON APERTURE received FDA 510(k) clearance on 2013-10-16, under 510(k) number K132236.

Who is the listed applicant for .DECIMAL PROTON APERTURE?

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

What is the FDA product code for .DECIMAL PROTON APERTURE?

The FDA product code for .DECIMAL PROTON APERTURE 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 .Decimal, 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.

K123015.DECIMAL PHOTON BLOCKK111759.DECIMAL ELECTRON APERTUREK091911BOLUS COMPENSATORK083672P.D SOFTWAREK071078.DECIMAL RANGE COMPENSATORK071077.DECIMAL APERTURE

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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 SystemsK131150CURA COMPENSATORCura Medical Technologies, LLCK123893CURA COLLIMATORCura Medical Technologies, LLCK123015.DECIMAL PHOTON BLOCK.Decimal, 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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