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FDA 510(k)

MOBILETT Impact

K-Number: K231577 · 2023-07-25

ApplicantSiemens Medical Solutions
Decision Date2023-07-25
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILETT Impact is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K231577. 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 MOBILETT Impact?

MOBILETT Impact is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Siemens Medical Solutions. The 510(k) number is K231577.

When did MOBILETT Impact receive FDA 510(k) clearance?

MOBILETT Impact received FDA 510(k) clearance on 2023-07-25, under 510(k) number K231577.

Who is the listed applicant for MOBILETT Impact?

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

What is the FDA product code for MOBILETT Impact?

The FDA product code for MOBILETT Impact is IZL.

Other records listing Siemens Medical Solutions 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.

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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.

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