FDA.reportPublic FDA data

Sim&Size

Primary DI
03665786000049
Brand
Sim&Size
Company
SIM&CURE
Model
V1.0.6
Published
2021-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular DevicesRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202322000Sim&SizeSim&Cure2020-12-31PZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665786000049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665786000049036657860000493665786000049

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266338887
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665786000018Sim&Sizev2.12026-03-13
03665786000070Sim&SizeV2.02025-02-11
03665786000032Sim&SizeV1.22023-03-14
03665786000063Sim&SizeV1.12022-06-24
03665786000056Sim&SizeV1.0.72021-06-06
03665786000025Sim&SizeVersion 1.0.52020-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665786000018Sim&SizeSIM&CUREPZO2026-03-13
08437025622016ANKYRASMENTICE SPAIN S.L.PZO2026-02-26
03665786000070Sim&SizeSIM&CUREPZO2025-02-11
03665786000032Sim&SizeSIM&CUREPZO2023-03-14
03665786000063Sim&SizeSIM&CUREPZO2022-06-24
03665786000056Sim&SizeSIM&CUREPZO2021-06-06
03665786000025Sim&SizeSIM&CUREPZO2020-07-30
B642SURGICALPREVIEW3300SurgicalPreviewENDOVANTAGE LLCPZO2019-11-27
B642SURGICALPREVIEW3200SurgicalPreviewENDOVANTAGE LLCPZO2019-11-05
B642SURGICALPREVIEW3100SurgicalPreviewENDOVANTAGE LLCPZO2019-10-23
B642SURGICALPREVIEW3000SurgicalPreviewENDOVANTAGE LLCPZO2019-09-12
B642SURGICALPREVIEW2600SurgicalPreviewENDOVANTAGE LLCPZO2019-06-07
B642SURGICALPREVIEW2500SurgicalPreviewENDOVANTAGE LLCPZO2019-04-30
B642SURGICALPREVIEW2400SurgicalPreviewENDOVANTAGE LLCPZO2019-02-07
B642SURGICALPREVIEW2300SurgicalPreviewENDOVANTAGE LLCPZO2019-01-28
B642SURGICALPREVIEW2200SurgicalPreviewENDOVANTAGE LLCPZO2018-12-07
B642SURGICALPREVIEW2100SurgicalPreviewENDOVANTAGE LLCPZO2018-11-30
B642SURGICALPREVIEW1200SurgicalPreviewENDOVANTAGE LLCPZO2018-04-29
B642SURGICALPREVIEW1100SurgicalPreviewENDOVANTAGE LLCPZO2018-04-16
B642SURGICALPREVIEW100SurgicalPreviewENDOVANTAGE LLCPZO2018-04-06