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FDA 510(k)

Televere Podiatry X-Ray System HF

K-Number: K180765 · 2018-04-20

ApplicantTelevere Systems, Inc.
Decision Date2018-04-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Televere Podiatry X-Ray System HF is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180765. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Televere Podiatry X-Ray System HF?

Televere Podiatry X-Ray System HF is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Televere Systems, Inc.. The 510(k) number is K180765.

When did Televere Podiatry X-Ray System HF receive FDA 510(k) clearance?

Televere Podiatry X-Ray System HF received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180765.

Who is the listed applicant for Televere Podiatry X-Ray System HF?

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

What is the FDA product code for Televere Podiatry X-Ray System HF?

The FDA product code for Televere Podiatry X-Ray System HF is KPR.

Other records listing Televere Systems, 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.

K181358Televere Digital Dental Imaging SystemK172124Televere Podiatry Digital Imaging SystemK170975Televere Digital Imaging System

Related Devices (Code: KPR)

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.

K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream HealthK252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems Co. , Ltd.

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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