FDA.reportPublic FDA data

VIDA|vision

Primary DI
00085246007008
Brand
VIDA|vision
Company
VIDA DIAGNOSTICS, INC.
Model
1.1
Device description
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosi
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083227000VIDA PULMONARY WORKSTATION 2 (PW2)Vida Diagnostics, Inc.2008-11-18JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085246007008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085246007008000852460070080852460070080085246007008

GMDN Terms#

Term, Definition table
TermDefinition
CT system application softwareAn application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-900-8432info@vidadiagnostics.com

Regulatory Flags#

DUNS number
195621060
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852426007022VIDA Insights3.x2022-08-04
00852426007015LungPrint 1.x2020-04-14
00852426007008VIDA|vision2.x2018-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838123748Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
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