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FDA 510(k)

DR 100s

K-Number: K191884 · 2019-08-09

ApplicantAgfa N.V.
Decision Date2019-08-09
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR 100s is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K191884. 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 DR 100s?

DR 100s is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Agfa N.V.. The 510(k) number is K191884.

When did DR 100s receive FDA 510(k) clearance?

DR 100s received FDA 510(k) clearance on 2019-08-09, under 510(k) number K191884.

Who is the listed applicant for DR 100s?

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

What is the FDA product code for DR 100s?

The FDA product code for DR 100s is IZL.

Other records listing Agfa N.V. 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.

K213469VALORYK212145DR 800 with DSA, DR 800K211790DX-D Imaging Package with XD DetectorsK193262DR 600 with TomosynthesisK183275DR 800 with Tomosynthesis

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

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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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