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FDA 510(k)

IQM Integral Quality Monitor (also IQM)

K-Number: K162629 · 2016-10-20

ApplicantIrt Systems
Decision Date2016-10-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQM Integral Quality Monitor (also IQM) is the device name listed in this FDA 510(k) record. The listed applicant is Irt Systems. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K162629. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQM Integral Quality Monitor (also IQM)?

IQM Integral Quality Monitor (also IQM) is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Irt Systems. The 510(k) number is K162629.

When did IQM Integral Quality Monitor (also IQM) receive FDA 510(k) clearance?

IQM Integral Quality Monitor (also IQM) received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162629.

Who is the listed applicant for IQM Integral Quality Monitor (also IQM)?

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

What is the FDA product code for IQM Integral Quality Monitor (also IQM)?

The FDA product code for IQM Integral Quality Monitor (also IQM) is IYE.

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, 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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