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FDA 510(k)

EOS

K-Number: K120721 · 2012-04-06

ApplicantEos Imaging
Decision Date2012-04-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EOS is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging. It received FDA 510(k) clearance on 2012-04-06 under 510(k) number K120721. 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 EOS?

EOS is a medical device that received FDA 510(k) clearance on 2012-04-06. The listed applicant is Eos Imaging. The 510(k) number is K120721.

When did EOS receive FDA 510(k) clearance?

EOS received FDA 510(k) clearance on 2012-04-06, under 510(k) number K120721.

Who is the listed applicant for EOS?

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

What is the FDA product code for EOS?

The FDA product code for EOS is MQB.

Related PubMed Literature

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.

PMID: 42375709Multimodal LLM vs. Human-Measured Features for AI Predictions of Autism in Home Videos.Algorithms ()

Other records listing Eos Imaging 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.

K251078AutoDensityK251747VEA Align; spineEOSK233920EOSedgeK240582VEA Align; spineEOSK231917VEA AlignK232086spineEOS

View all 12 devices →

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

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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