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FDA 510(k)

IDX-60 INTRAORAL X-RAY

K-Number: K993958 · 2000-02-14

ApplicantX-Cel X-Ray Corp.
Decision Date2000-02-14
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IDX-60 INTRAORAL X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel X-Ray Corp.. It received FDA 510(k) clearance on 2000-02-14 under 510(k) number K993958. 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 IDX-60 INTRAORAL X-RAY?

IDX-60 INTRAORAL X-RAY is a medical device that received FDA 510(k) clearance on 2000-02-14. The listed applicant is X-Cel X-Ray Corp.. The 510(k) number is K993958.

When did IDX-60 INTRAORAL X-RAY receive FDA 510(k) clearance?

IDX-60 INTRAORAL X-RAY received FDA 510(k) clearance on 2000-02-14, under 510(k) number K993958.

Who is the listed applicant for IDX-60 INTRAORAL X-RAY?

The FDA 510(k) record lists X-Cel X-Ray Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDX-60 INTRAORAL X-RAY?

The FDA product code for IDX-60 INTRAORAL X-RAY is MUH.

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 X-Cel X-Ray Corp. 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.

K930699M6-MK871116X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90RK811230X-CELL X-RAY #'S P-75W/P-75M

Related Devices (Code: MUH)

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.

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.

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