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FDA 510(k)

IMIX DIGITAL THORAX SYSTEM

K-Number: K974863 · 1998-03-17

ApplicantAdvanced Instrument Development, Inc.
Decision Date1998-03-17
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMIX DIGITAL THORAX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrument Development, Inc.. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K974863. 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 IMIX DIGITAL THORAX SYSTEM?

IMIX DIGITAL THORAX SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Advanced Instrument Development, Inc.. The 510(k) number is K974863.

When did IMIX DIGITAL THORAX SYSTEM receive FDA 510(k) clearance?

IMIX DIGITAL THORAX SYSTEM received FDA 510(k) clearance on 1998-03-17, under 510(k) number K974863.

Who is the listed applicant for IMIX DIGITAL THORAX SYSTEM?

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

What is the FDA product code for IMIX DIGITAL THORAX SYSTEM?

The FDA product code for IMIX DIGITAL THORAX SYSTEM is KPR.

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Other records listing Advanced Instrument Development, 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.

K872445POWER-AID INDEPENDENT X-RAY POWER SOURCEK827525AUTOMATIC EXPOSURE CONTROL TYPE A3300K813128MOBIL-AID AUTOMATIC EXPOSURE CONTROLK791933CONVERSION CONTRACTOR TIMER KIT

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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