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FDA 510(k)

DR VISION NEO, DR VISION DOU

K-Number: K080614 · 2008-06-20

ApplicantAlmana Medical Imaging
Decision Date2008-06-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR VISION NEO, DR VISION DOU is the device name listed in this FDA 510(k) record. The listed applicant is Almana Medical Imaging. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K080614. 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 DR VISION NEO, DR VISION DOU?

DR VISION NEO, DR VISION DOU is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Almana Medical Imaging. The 510(k) number is K080614.

When did DR VISION NEO, DR VISION DOU receive FDA 510(k) clearance?

DR VISION NEO, DR VISION DOU received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080614.

Who is the listed applicant for DR VISION NEO, DR VISION DOU?

The FDA 510(k) record lists Almana Medical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR VISION NEO, DR VISION DOU?

The FDA product code for DR VISION NEO, DR VISION DOU is KPR.

Related Clinical Trials

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Other records listing Almana Medical Imaging 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.

K100001MOBIVISIONK082064RADVISION ET DIAGNOSTIC X-RAY SYSTEMK080847RFVISION, MODEL 9.9DK072659RAD VISION, MODELS E AND EU

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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