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FDA 510(k)

CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)

K-Number: K071682 · 2007-08-15

ApplicantAlara, Inc.
Decision Date2007-08-15
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) is the device name listed in this FDA 510(k) record. The listed applicant is Alara, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071682. 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 CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)?

CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Alara, Inc.. The 510(k) number is K071682.

When did CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) receive FDA 510(k) clearance?

CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071682.

Who is the listed applicant for CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)?

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

What is the FDA product code for CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)?

The FDA product code for CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) is MQB.

Related Clinical Trials

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.

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Other records listing Alara, 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.

K102479ALARA T210 COMPUTED RADIOGRAPHY SYSTEMK062390CRYSTALVIEW R200K061538ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200K032210ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEMK000162METRISCAN BONE DENSITY SYSTEM

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

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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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