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FDA 510(k)

KALARE DIAGNOSTIC X-RAY TABLE SYSTEM

K-Number: K110785 · 2011-05-27

ApplicantToshiba Medical Systems Coporation, Japan
Decision Date2011-05-27
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KALARE DIAGNOSTIC X-RAY TABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Coporation, Japan. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K110785. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALARE DIAGNOSTIC X-RAY TABLE SYSTEM?

KALARE DIAGNOSTIC X-RAY TABLE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Toshiba Medical Systems Coporation, Japan. The 510(k) number is K110785.

When did KALARE DIAGNOSTIC X-RAY TABLE SYSTEM receive FDA 510(k) clearance?

KALARE DIAGNOSTIC X-RAY TABLE SYSTEM received FDA 510(k) clearance on 2011-05-27, under 510(k) number K110785.

Who is the listed applicant for KALARE DIAGNOSTIC X-RAY TABLE SYSTEM?

The FDA 510(k) record lists Toshiba Medical Systems Coporation, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALARE DIAGNOSTIC X-RAY TABLE SYSTEM?

The FDA product code for KALARE DIAGNOSTIC X-RAY TABLE SYSTEM is JAA.

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Other records listing Toshiba Medical Systems Coporation, Japan 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.

K121422APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEMK113466AQUILION ONEK1123664CH FLEX SPEEDERK1112514CH FLEX SPEEDER

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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