Spectral CT Verida Family

FDA 510(k) K253649 · Philips Medical Systems Technologies , Ltd.

Substantially Equivalent

510(k) numberK253649

Submission

Device name
Spectral CT Verida Family
Applicant
Philips Medical Systems Technologies , Ltd.
Haifa, IL
Received
November 20, 2025
Decision date
March 27, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAK – System, X-Ray, Tomography, Computed
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Other 510(k)s with product code JAK

510(k)DeviceApplicantDecision
K253836FCT iStream Phase 2JAK · Traditional Fujifilm Corporation09/04/2026SE
K253450BodyTom Elite (NL4000)JAK · Traditional NeuroLogica Corp., a Samsung Company07/28/2026SE
K253770CardIQ SuiteJAK · Traditional GE Medical Systems SCS07/21/2026SE
K253560Enhanced Boundary for PCCTJAK · Traditional Ge Medical Systems, LLC06/24/2026SE
K253026Respiratory Gating for Scanners (2.1)JAK · Traditional Varian Medical Systems, Inc.06/04/2026SE
K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional Canon Medical Systems Corporation05/20/2026SE
K253686True Definition DLJAK · Traditional Ge Healthcare Japan Corporation03/23/2026SE
K252992CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional Philips Healthcare (Suzhou) Co., Ltd.03/23/2026SE
K253574SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional Siemens Medical Solutions USA, Inc.03/20/2026SE
K253520Photonova Spectra, Photonova Spectra SelectJAK · Traditional Ge Medical Systems, LLC03/20/2026SE

More from Ge Medical Systems, LLC

510(k)DeviceDecision
K244008Spectral CTJAK · Traditional 05/16/2025SE
K240844Spectral CT 7500 RTJAK · Traditional 10/18/2024SE
K240822Image Management V15LLZ · Traditional 04/24/2024SE
K173588Illumeo SystemLLZ · Special 01/12/2018SE

Questions and answers

When was Spectral CT Verida Family cleared by the FDA?

Spectral CT Verida Family (K253649) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 127 days after the submission was received.

What is the product code of K253649?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.