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FDA 510(k)

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE

K-Number: K013176 · 2001-10-16

ApplicantAfp Imaging Corp.
Decision Date2001-10-16
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE 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 2001-10-16 under 510(k) number K013176. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE?

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Afp Imaging Corp.. The 510(k) number is K013176.

When did MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE receive FDA 510(k) clearance?

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE received FDA 510(k) clearance on 2001-10-16, under 510(k) number K013176.

Who is the listed applicant for MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE?

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 MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE?

The FDA product code for MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE is EHD.

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Related Devices (Code: EHD)

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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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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