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FDA 510(k)

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB

K-Number: K101289 · 2010-08-03

ApplicantAir Techniques, Inc.
Decision Date2010-08-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB is the device name listed in this FDA 510(k) record. The listed applicant is Air Techniques, Inc.. It received FDA 510(k) clearance on 2010-08-03 under 510(k) number K101289. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB?

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB is a medical device that received FDA 510(k) clearance on 2010-08-03. The listed applicant is Air Techniques, Inc.. The 510(k) number is K101289.

When did SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB receive FDA 510(k) clearance?

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB received FDA 510(k) clearance on 2010-08-03, under 510(k) number K101289.

Who is the listed applicant for SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB?

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

What is the FDA product code for SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB?

The FDA product code for SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB is MQB.

Related Clinical Trials

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Other records listing Air Techniques, 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.

K191623ScanX Touch/ScanX Duo TouchK190949ScanX Barrier EnvelopesK090169SPECTRA FLUORESCENCE CARIES DETECTION DEVICEK052271RINSENDOK050693ACCENTK042397SCANX 14

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Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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