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FDA 510(k)

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM

K-Number: K123419 · 2012-12-27

ApplicantAfp Imaging Corp.
Decision Date2012-12-27
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Afp Imaging Corp.. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K123419. 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 EVA SELECT DIGITAL DENTAL IMAGING SYSTEM?

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Afp Imaging Corp.. The 510(k) number is K123419.

When did EVA SELECT DIGITAL DENTAL IMAGING SYSTEM receive FDA 510(k) clearance?

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM received FDA 510(k) clearance on 2012-12-27, under 510(k) number K123419.

Who is the listed applicant for EVA SELECT DIGITAL DENTAL IMAGING SYSTEM?

The FDA 510(k) record lists Afp Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVA SELECT DIGITAL DENTAL IMAGING SYSTEM?

The FDA product code for EVA SELECT DIGITAL DENTAL IMAGING SYSTEM is MUH.

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Other records listing Afp Imaging 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.

K072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEMK041120EV APAN DIGITAL, MODEL K1VSM2000K030647EVA DIGITAL DENTAL X-RAY SYSTEMK014144EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804K013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWAREK974619SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM

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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

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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