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FDA 510(k)

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

K-Number: K012546 · 2001-11-02

ApplicantSedecal USA, Inc.
Decision Date2001-11-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM 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 2001-11-02 under 510(k) number K012546. 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 OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM?

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Sedecal USA, Inc.. The 510(k) number is K012546.

When did OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM receive FDA 510(k) clearance?

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM received FDA 510(k) clearance on 2001-11-02, under 510(k) number K012546.

Who is the listed applicant for OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM?

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 OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM?

The FDA product code for OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM is KPR.

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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.

K042361DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 DK012663EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)

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

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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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