5727669

by GE Medical Systems, LLC

5727669 is a Class I device made by GE Medical Systems, LLC, cleared under FDA 510(k) K162268 on 3 Nov 2016 and listed in FDA GUDID since 13 Sep 2017 (UDI-DI 00840682122603), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00840682122603 UDI-DI	Date13 Sep 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK162268	Date3 Nov 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00840682122603
FDA 510(k) database 510(k) number K162268

Across registries

2 registries list this device

FDA 510(k) K162268 decided 3 Nov 2016 Active
FDA GUDID UDI-DI 00840682122603 listed 13 Sep 2017 Listed

Recalls

3 recalls · 2 ongoing · FDA

- Ongoing Z-0875-2026 FDA Class II initiated 24 Oct 2025
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).
- Ongoing Z-0862-2024 FDA Class II initiated 26 Dec 2023
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
- Terminated Z-2131-2019 FDA Class II initiated 16 May 2019
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

Timeline

5 dated events

3 Nov 2016 Cleared FDA 510(k) K162268
13 Sep 2017 Listed FDA GUDID 00840682122603
16 May 2019 Recall initiated FDA recalls Z-2131-2019
26 Dec 2023 Recall initiated FDA recalls Z-0862-2024
24 Oct 2025 Recall initiated FDA recalls Z-0875-2026

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Stationary mammographic x-ray system, digital
Model / reference: 5727669

Primary DI / UDI-DI: 00840682122603
510(k) Number: K162268
FDA product code: IZO, FMQ, IWX, IXJ, ITY, MUE, IZW
GMDN term: Stationary mammographic x-ray system, digital

Device class: Class I
Regulation number: 892.1700, 880.6760, 892.6500, 892.1910, 892.1760, 892.1715, 892.1610
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)