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FDA 510(k)

SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS

K-Number: K090238 · 2009-02-27

ApplicantSedecal., Sa.
Decision Date2009-02-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K090238. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS?

SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Sedecal., Sa.. The 510(k) number is K090238.

When did SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS receive FDA 510(k) clearance?

SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS received FDA 510(k) clearance on 2009-02-27, under 510(k) number K090238.

Who is the listed applicant for SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS?

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 X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS?

The FDA product code for SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS is KPR.

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Other records listing Sedecal., Sa. as applicant

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Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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