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FDA 510(k)

SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR

K-Number: K043002 · 2004-11-18

ApplicantSedecal., Sa.
Decision Date2004-11-18
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2004-11-18 under 510(k) number K043002. 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 SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR?

SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR is a medical device that received FDA 510(k) clearance on 2004-11-18. The listed applicant is Sedecal., Sa.. The 510(k) number is K043002.

When did SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR receive FDA 510(k) clearance?

SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR received FDA 510(k) clearance on 2004-11-18, under 510(k) number K043002.

Who is the listed applicant for SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR?

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

What is the FDA product code for SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR?

The FDA product code for SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR is IZL.

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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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