Lumify Diagnostic Ultrasound System

by Philips Health Care

510(k) K192226

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K192226↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK192226	Date6 Sep 2019Cleared	StatusActive

Recalls

5 recalls · 5 ongoing · FDA

5 recalls, same reason
- Ongoing Z-1625-2026 FDA Class III initiated 5 Sep 2025 on shared 510(k) K192226
- Ongoing Z-2354-2025 FDA Class III initiated 3 Jul 2025
- Ongoing Z-2392-2025 FDA Class III initiated 3 Jul 2025
- Ongoing Z-2374-2025 FDA Class III initiated 3 Jul 2025
- Ongoing Z-2391-2025 FDA Class III initiated 3 Jul 2025
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K192226
FDA Product Code: IYN

Device Class: Class II
Regulation: 21 CFR Part 892.1550
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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