FDA.report

Spectral CT Verida

Primary DI
00884838123748
Brand
Spectral CT Verida
Company
Philips Medical Systems Nederland B.V.
Model
Spectral CT Verida
Catalog number
728345
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JAKSystem, x-ray, tomography, computed

Product Code Classifications

CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions

SubmissionSupplement
K253649000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253649000Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.2026-03-27JAK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884838123748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838123748008848381237488848381237480884838123748

GMDN Terms

TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Regulatory Flags

DUNS number
413819707
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00884838126398Spectral CT Verida RTSpectral CT Verida RT7283572026-05-26
00884838127555Upgrade Spectral CT VeridaUpgrade Spectral CT Verida7283562026-05-26
00884838127562Upgrade Spectral CT Verida RTUpgrade Spectral CT Verida RT7283722026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Upgrade Spectral CT 7500 SW5.47283752026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Upgrades Spectral CT 7500 RT SW5.47283552026-05-26
00884838074798IntelliSpace PACS Anywhere1.4.x8375082026-02-07
00884838104402IngeniaUpgrade to MR 77007821302026-01-27
00884838128415Ingenia BlueSeal SE7821932026-01-07
00884838128422Ingenia BlueSeal XE7821922026-01-07
00884838128439Ingenia MR 77007821992026-01-07
00884838128446Ingenia MR 5300 7821962026-01-07
00884838128453Ingenia Ingenia Elition S7821972026-01-07
00884838128460Ingenia Ingenia Elition X7821982026-01-07
00884838128477Ingenia, MR5300, MR7700, AchievaIngenia Ambition S7821942026-01-07
00884838128484Ingenia 3.0TIngenia Ambition X7821952026-01-07
00884838128514IngeniaEvolution Upgrade 3.0T 7822022026-01-07
00884838128521Ingenia ElitionSmartPath to Ingenia Elition X7822042026-01-07
00884838128552IngeniaEvolution Upgrade 1.5T 7822012026-01-07
00884838128569MR 7700Upgrade to MR 7700 7822062026-01-07
00884838128576MR 7700SmartPath to MR 77007822072026-01-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00884838126398Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127555Upgrade Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127562Upgrade Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Philips Medical Systems Nederland B.V.JAK2026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Philips Medical Systems Nederland B.V.JAK2026-05-26
10815411020847OmniTom Elite PCDNEUROLOGICA CORP.JAK2026-03-23
04987670104701CT SCANNERCANON INC.JAK2026-03-01
04987670106538CT SCANNERCANON INC.JAK2026-03-01
19356870000038CT:VQ4DMEDICAL LIMITEDJAK2026-01-28
00195278932341Spectral Color OverlayGE MEDICAL SYSTEMS, INC.JAK2026-01-26
00195278932358Spectral Bone MarrowGE MEDICAL SYSTEMS, INC.JAK2026-01-26
00195278932365Head Auto ViewsGE MEDICAL SYSTEMS, INC.JAK2026-01-26
04068151048056Biograph Trinion.X EP5 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.JAK2026-01-09
04068151048087Biograph Trinion.X EP5 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.JAK2026-01-09
00884838117921Spectral CT 7500 RTPhilips Medical Systems Nederland B.V.JAK2025-12-23
07290018016206HealthOSTNANO-X AI LTDJAK2025-12-14
01935687000038CT:VQ4DMEDICAL LIMITEDJAK2025-12-08
04056869295541SOMATOM X.citeSiemens Shanghai Medical Equipment Ltd.JAK2025-11-30
04056869295558SOMATOM X.ceedSiemens Shanghai Medical Equipment Ltd.JAK2025-11-30
04056869973500SOMATOM Pro.PulseSiemens Shanghai Medical Equipment Ltd.JAK2025-11-30
04056869290355syngo.CT CaScoringSiemens Healthcare GmbHJAK2025-11-24
00198953049174RevolutionHangwei General Electric Medical System Co., Ltd.JAK2025-10-15
00198953049631RevolutionHangwei GE Medical Systems Co., Ltd.JAK2025-09-09
00198953061329NMCT 860G E MEDICAL SYSTEMS ISRAEL LTD.JAK2025-09-09
00198953061336NMCT 850G E MEDICAL SYSTEMS ISRAEL LTD.JAK2025-09-09
00195278943934RevolutionHangwei GE Medical Systems Co., Ltd.JAK2025-08-22
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.JAK2025-08-03
B720BX360ELUNG220e-LungBRAINOMIX LIMITEDJAK2025-07-25
M722C25133CA241430ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-06-17
M722CC25133CA241430ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-06-17