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FDA 510(k)

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D

K-Number: K042361 · 2004-09-29

ApplicantSedecal USA, Inc.
Decision Date2004-09-29
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal USA, Inc.. It received FDA 510(k) clearance on 2004-09-29 under 510(k) number K042361. 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 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D?

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D is a medical device that received FDA 510(k) clearance on 2004-09-29. The listed applicant is Sedecal USA, Inc.. The 510(k) number is K042361.

When did DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D receive FDA 510(k) clearance?

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D received FDA 510(k) clearance on 2004-09-29, under 510(k) number K042361.

Who is the listed applicant for DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D?

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

What is the FDA product code for DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D?

The FDA product code for DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D is IZL.

Related Clinical Trials

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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Other records listing Sedecal USA, Inc. 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.

K012546OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEMK012663EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)

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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