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FDA 510(k)

PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0

K-Number: K020436 · 2002-02-22

ApplicantSedecal., Sa.
Decision Date2002-02-22
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K020436. 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 PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0?

PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Sedecal., Sa.. The 510(k) number is K020436.

When did PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 receive FDA 510(k) clearance?

PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 received FDA 510(k) clearance on 2002-02-22, under 510(k) number K020436.

Who is the listed applicant for PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0?

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 PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0?

The FDA product code for PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 is IZL.

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Other records listing Sedecal., Sa. 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.

K232185SM-IVK222951SM-VK221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.K212291PHOENIXK203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsK202293Radiographic System Challenge X

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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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