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Crispics

by Merlin Engineering Works, Inc.

510(k) K954211

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK954211 Date5 Dec 1995ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Crispics is a Class II X-ray imaging system designed for radiography applications. It is intended for capturing high-quality radiographic images of patients, facilitating diagnostic evaluations in clinical settings. This device operates under the product code LLZ, as classified by the FDA, and is intended for use in radiology procedures.

The Crispics is supplied by Merlin Engineering Works, Inc., and has received FDA 510(k) clearance under the traditional review pathway, with a clearance date of December 5, 1995. It is intended for use in radiology departments and is not described as single-use or reusable in the available data. No specific sterility, MRI safety, or size details are provided in the regulatory records. The device is governed by the FDA’s radiology advisory committee (RA) and is associated with the K-number K954211.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Crispics X-ray imaging system designed for?

    The Crispics is a Class II X-ray imaging system specifically designed for capturing high-quality radiographic images of patients. It is intended to support diagnostic evaluations in radiology departments, enabling clinicians to visualize internal structures for accurate medical assessments.

  • How is the Crispics supplied and what is its regulatory status?

    The Crispics is supplied by Merlin Engineering Works, Inc. It has received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a legally marketed predicate device. The clearance was granted on December 5, 1995, under K-number K954211 and product code LLZ.

  • Is the Crispics intended for single-use or reusable applications?

    The regulatory records for the Crispics do not explicitly specify whether it is intended for single-use or reusable applications. Clinicians should follow manufacturer guidelines and facility protocols to ensure proper use and maintenance based on their specific operational needs.

  • What advisory committee oversees the Crispics?

    The Crispics is governed by the FDA’s Radiology (RA) advisory committee. This committee provides expert guidance on radiology-related devices, including imaging systems like the Crispics, to ensure their safety and effectiveness in clinical settings.

  • Are there any details provided about sterility or MRI safety for the Crispics?

    The available regulatory records for the Crispics do not include specific information regarding sterility or MRI safety. Clinicians should consult the manufacturer’s instructions or additional documentation for any relevant details before use.