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FDA 510(k)

XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND

K-Number: K063247 · 2006-11-22

ApplicantImaging Dynamics Company , Ltd.
Decision Date2006-11-22
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K063247. 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 XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND?

XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K063247.

When did XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND receive FDA 510(k) clearance?

XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND received FDA 510(k) clearance on 2006-11-22, under 510(k) number K063247.

Who is the listed applicant for XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND?

The FDA 510(k) record lists Imaging Dynamics Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND?

The FDA product code for XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND is KPR.

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Other records listing Imaging Dynamics Company , Ltd. 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.

K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCIK171169Aquarius 8600 1417TG and Aquarius 8600 1717TGK171175Aquarius 8600 1417WCK170202Aquarius 8600K111098INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLANK071401X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM

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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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