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Model DGH 6000 Scanmate A

by Dgh Technology Inc.

510(k) K093371

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093371↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK093371 Date5 Apr 2010ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
IYO
FDA applicant
Dgh Technology, Inc.
Device class
Class II
Regulation
21 CFR Part 892.1560
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model DGH 6000 Scanmate A is an A-scan ultrasound biometry device designed for ocular measurements. It provides real-time axial length, anterior chamber depth, and lens thickness assessments, enabling precise intraocular lens (IOL) power calculations for cataract surgery planning.

This portable device is intended for use in clinical ophthalmology settings and is supplied as a reusable instrument. It has received FDA 510(k) clearance under the Radiology advisory committee and complies with the Medical Device Directive (MDD). Sterility and MRI safety specifications are not indicated in the available data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical measurements does the Model DGH 6000 Scanmate A provide, and how are they used in cataract surgery planning?

    The Model DGH 6000 Scanmate A performs real-time A-scan ultrasound biometry, measuring axial length, anterior chamber depth, and lens thickness. These metrics are critical for calculating the precise power of intraocular lenses (IOLs) during cataract surgery planning, ensuring accurate lens placement and patient outcomes.

  • Is the Model DGH 6000 Scanmate A designed for single-use or reusable clinical settings, and what maintenance considerations should be noted?

    The device is explicitly supplied as a reusable instrument, meaning it is intended for repeated use in clinical ophthalmology settings. Since it is not sterile by default, proper cleaning and maintenance protocols must be followed to ensure reliability and patient safety between uses.

  • How portable is the Model DGH 6000 Scanmate A, and what type of clinical environments is it intended for?

    The device is described as portable, making it suitable for use in various clinical ophthalmology settings, including outpatient clinics, surgical centers, or mobile eye care units where space or flexibility is a consideration.

  • What regulatory pathways does the Model DGH 6000 Scanmate A follow, and which advisory committee was involved in its FDA clearance?

    The device received FDA 510(k) clearance under the Radiology advisory committee (RA), with a decision dated April 5, 2010. It was also compliant with the Medical Device Directive (MDD). The clearance was granted as substantially equivalent (SESE) to a predicate device, following a traditional review process.