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FDA 510(k)

Televere Digital Imaging System

K-Number: K170975 · 2017-05-01

ApplicantTelevere Systems
Decision Date2017-05-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Televere Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K170975. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Televere Digital Imaging System?

Televere Digital Imaging System is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Televere Systems. The 510(k) number is K170975.

When did Televere Digital Imaging System receive FDA 510(k) clearance?

Televere Digital Imaging System received FDA 510(k) clearance on 2017-05-01, under 510(k) number K170975.

Who is the listed applicant for Televere Digital Imaging System?

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

What is the FDA product code for Televere Digital Imaging System?

The FDA product code for Televere Digital Imaging System is MQB.

Other records listing Televere Systems 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 SystemK180765Televere Podiatry X-Ray System HFK172124Televere Podiatry Digital Imaging System

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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