Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Optima XR240amx, AutoGrid

K-Number: K173602 · 2018-01-12

ApplicantGe Medical Systems, LLC
Decision Date2018-01-12
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optima XR240amx, AutoGrid is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K173602. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optima XR240amx, AutoGrid?

Optima XR240amx, AutoGrid is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K173602.

When did Optima XR240amx, AutoGrid receive FDA 510(k) clearance?

Optima XR240amx, AutoGrid received FDA 510(k) clearance on 2018-01-12, under 510(k) number K173602.

Who is the listed applicant for Optima XR240amx, AutoGrid?

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

What is the FDA product code for Optima XR240amx, AutoGrid?

The FDA product code for Optima XR240amx, AutoGrid is IZL.

Other records listing Ge Medical Systems, LLC 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.

K253808AIR Recon DLK253560Enhanced Boundary for PCCTK253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmK253520Photonova Spectra, Photonova Spectra SelectK253780SIGNA™ BoltK253779SIGNA™ Sprint Select

View all 47 devices →

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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.

↑