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FDA 510(k)

QuantumCam

K-Number: K161674 · 2016-10-20

ApplicantDdd-Diagnostic A/S
Decision Date2016-10-20
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QuantumCam is a medical device manufactured by Ddd-Diagnostic A/S. It received FDA 510(k) clearance on 2016-10-20 under approval number K161674. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuantumCam?

QuantumCam is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Ddd-Diagnostic A/S. The 510(k) number is K161674.

When was QuantumCam approved by the FDA?

QuantumCam received FDA 510(k) clearance on 2016-10-20, under approval number K161674.

What company makes QuantumCam?

QuantumCam is manufactured by Ddd-Diagnostic A/S.

What is the FDA product code for QuantumCam?

The FDA product code for QuantumCam is KPS.

Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB

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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