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FDA 510(k)

IMAGE-X 70 INTRAORAL X-RAY SYSTEM

K-Number: K930761 · 1993-05-25

ApplicantAfp Imaging Corp.
Decision Date1993-05-25
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMAGE-X 70 INTRAORAL X-RAY 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 1993-05-25 under 510(k) number K930761. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE-X 70 INTRAORAL X-RAY SYSTEM?

IMAGE-X 70 INTRAORAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-25. The listed applicant is Afp Imaging Corp.. The 510(k) number is K930761.

When did IMAGE-X 70 INTRAORAL X-RAY SYSTEM receive FDA 510(k) clearance?

IMAGE-X 70 INTRAORAL X-RAY SYSTEM received FDA 510(k) clearance on 1993-05-25, under 510(k) number K930761.

Who is the listed applicant for IMAGE-X 70 INTRAORAL X-RAY 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 IMAGE-X 70 INTRAORAL X-RAY SYSTEM?

The FDA product code for IMAGE-X 70 INTRAORAL X-RAY SYSTEM is EAP.

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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.

K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEMK072357NEWTOM 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 SOFTWARE

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Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, 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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