FDA 510(k)

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

K-Number: K041834 · 2004-12-03

Decision Date2004-12-03

Product CodeMUH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont USA, Inc.. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K041834. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM?

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Takara Belmont USA, Inc.. The 510(k) number is K041834.

When did ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM receive FDA 510(k) clearance?

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM received FDA 510(k) clearance on 2004-12-03, under 510(k) number K041834.

Who is the listed applicant for ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM?

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

What is the FDA product code for ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM?

The FDA product code for ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM is MUH.

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Other records listing Takara Belmont USA, Inc. as applicant

K102456INTRAORAL BELSENSOR GOLD K072273BELMONT QUOLIS 5000 SERIES DENTAL UNIT K062529BELMAX CM MODEL X168 K042260PHOT-X II, MODEL 303 K040748ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

Related Devices (Code: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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.