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Merlin Engineering Works, Inc.

United StatesFDA applicant, unverified

Devices
8

What Merlin Engineering Works, Inc. makes

Merlin Engineering Works, Inc. manufactures ultrasound imaging accessories, including real-time imaging systems like the MultiPics (ME-977) and CRISPICS, as well as scan converters such as the DownScan LT, UpScan 120, and UniScan. Their portfolio also includes split-screen and multi-image display devices like the SplitScreen (ME-975) and DownScan 120.

These devices are classified under FDA categories Class I and Class II, with regulatory records supported by 510(k) clearances. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • Multipics(Me-977) Ref K971154

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Downscan Lt Ref K974882

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Splitscreen (Me-975) Ref K971153

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Upscan 120 Ref K970450

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Upscan Ref K933512

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Downscan 120 Ref K970451

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Uniscan Ref K953398

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Crispics Ref K954211

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Merlin Engineering Works, Inc. have in the registry?

The registry currently lists 8 devices for Merlin Engineering Works, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Merlin Engineering Works, Inc.'s devices?

Among its 8 most recently registered devices, Merlin Engineering Works, Inc. has devices listed in FDA 510(k) (8 devices).

What risk classes do Merlin Engineering Works, Inc.'s devices fall under?

Among its 8 most recently registered devices, the classes recorded for Merlin Engineering Works, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Merlin Engineering Works, Inc. in the registry?

The most recently registered devices listed for Merlin Engineering Works, Inc. include MULTIPICS(ME-977), DOWNSCAN LT, SPLITSCREEN (ME-975) and UPSCAN 120.

Generated automatically from registry data and not verified by a human reviewer.