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Chrysalis

by Meta Imaging Solutions, LLC

510(k) K080655

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 NumberK080655 Date9 May 2008ClearedStatusActive

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Chrysalis is a Class II X-ray system intended to accessorize stationary X-ray systems. It is used in radiology.

The device received FDA 510(k) clearance under K-number K080655 in 2008. It is manufactured by Meta Imaging Solutions, LLC.

Questions

AI-generated answers, 27 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 is the Chrysalis device used for?

    The Chrysalis device is intended to accessorize stationary X-ray systems, meaning it is used as an add-on component to enhance or support the functionality of existing fixed X-ray equipment in radiology departments.

  • Who manufactures the Chrysalis X-ray system accessory?

    The Chrysalis device is manufactured by Meta Imaging Solutions, LLC, a company based in Old Lyme, Connecticut, as indicated in the FDA 510(k) submission details.

  • What regulatory pathway was used for the Chrysalis device clearance?

    The Chrysalis device received FDA 510(k) clearance under K-number K080655, which means it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) submission process.

  • When was the Chrysalis device cleared by the FDA?

    The Chrysalis device received its FDA 510(k) clearance on May 9, 2008, following submission on March 7, 2008, under K-number K080655.

  • What classification does the Chrysalis device hold under FDA regulations?

    The Chrysalis device is classified as a Class II medical device, as indicated by the device_class=2 field in the openfda data, which subjects it to special controls in addition to general controls.