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FDA 510(k)

AQUILA 320 D / AQUILA 320 S

K-Number: K201340 · 2020-06-19

ApplicantVmi Tecnologias Ltda
Decision Date2020-06-19
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AQUILA 320 D / AQUILA 320 S is the device name listed in this FDA 510(k) record. The listed applicant is Vmi Tecnologias Ltda. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K201340. 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 AQUILA 320 D / AQUILA 320 S?

AQUILA 320 D / AQUILA 320 S is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Vmi Tecnologias Ltda. The 510(k) number is K201340.

When did AQUILA 320 D / AQUILA 320 S receive FDA 510(k) clearance?

AQUILA 320 D / AQUILA 320 S received FDA 510(k) clearance on 2020-06-19, under 510(k) number K201340.

Who is the listed applicant for AQUILA 320 D / AQUILA 320 S?

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

What is the FDA product code for AQUILA 320 D / AQUILA 320 S?

The FDA product code for AQUILA 320 D / AQUILA 320 S is IZL.

Other records listing Vmi Tecnologias Ltda 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.

K210151Digimamo DK202388Apolo D / Apolo S

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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