FDA.reportPublic FDA data

Cydar Maps

Primary DI
05060508110057
Brand
Cydar Maps
Company
CYDAR LIMITED
Model
EV
Device description
Cydar Maps Software as a Medical Device. Indicated for vascular surgery procedure planning, intraoperative navigation and post-operative review of patient.
Published
2026-05-27
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

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212442000Cydar EV (Series B) and Cydar EV MapsCydar , Ltd.2021-12-03OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060508110057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060508110057050605081100575060508110057

GMDN Terms#

Term, Definition table
TermDefinition
Vascular modelling softwareA stand-alone software application intended to aid assessment of vascular stenosis and/or endovascular interventions, by producing a three-dimensional (3-D) cardiovascular model which has features of predicted blood flow data and/or endovascular device deployments. It typically uses computed tomography (CT) images and may be intended as an alternative to invasive techniques (i.e., invasive blood pressure, invasive fractional flow reserve, angiography); it is not intended to store patient records. It is designed to be installed on an off-the-shelf computer/smart device.

Regulatory Flags#

DUNS number
218286403
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
05060508110002Cydar EVEV-22017-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00857088008684TrackXTrackX Technology, LLCOWB2026-05-11
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
00841962120548Alpine Stirrups, Metric, LeftQfixOWB2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixOWB2026-04-14
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00850073646120TrackXTrackX Technology, LLCOWB2026-04-08
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-03-25
00850079606050EmitterOXOS Medical, Inc.OWB2026-03-25
00850073646106TrackXTrackX Technology, LLCOWB2026-02-24
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
00841962120388Lumen AirShuttleQfixOWB2025-12-02
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
00850073646045TrackXTrackX Technology, LLCOWB2025-10-24
00850073646052TrackXTrackX Technology, LLCOWB2025-10-24
00850073646069TrackXTrackX Technology, LLCOWB2025-10-24
00850073646076TrackXTrackX Technology, LLCOWB2025-10-24
00850073646083TrackXTrackX Technology, LLCOWB2025-10-24
00850073646113TrackXTrackX Technology, LLCOWB2025-10-15
00841962119467Alpine StirrupsQfixOWB2025-07-09
00841962119474Alpine StirrupsQfixOWB2025-07-09
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
08809244060465GenorayGENORAY CO., LTD.OWB2025-05-02
07613327664089Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWB2025-02-11