FDA.reportPublic FDA data

OnDemand3DTM

Primary DI
08800023100006
Brand
OnDemand3DTM
Company
Cybermed Inc.
Model
1.0
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070464000ONDEMAND3DCybermed, Inc.2007-03-16LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023100006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023100006088000231000068800023100006

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

Contacts#

Phone, Email table
PhoneEmail
949-341-0623alex@cybermed.co.kr

Regulatory Flags#

DUNS number
688248447
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800023142327Link AbutmentICLAHM4041S2024-10-31
08800023142334Link AbutmentICLAHM4042S2024-10-31
08800023142341Link AbutmentICLAHM4043S2024-10-31
08800023142358Link AbutmentICLAHM4044S2024-10-31
08800023142365Link AbutmentICLAHM4061S2024-10-31
08800023142372Link AbutmentICLAHM4062S2024-10-31
08800023142389Link AbutmentICLAHM4063S2024-10-31
08800023142396Link AbutmentICLAHM4064S2024-10-31
08800023142402Link AbutmentICLAHR4541S2024-10-31
08800023142419Link AbutmentICLAHR4542S2024-10-31
08800023142426Link AbutmentICLAHR4543S2024-10-31
08800023142433Link AbutmentICLAHR4544S2024-10-31
08800023142440Link AbutmentICLAHR4561S2024-10-31
08800023142457Link AbutmentICLAHR4562S2024-10-31
08800023142464Link AbutmentICLAHR4563S2024-10-31
08800023142471Link AbutmentICLAHR4564S2024-10-31
08800023142488Link AbutmentICLAHR5541S2024-10-31
08800023142495Link AbutmentICLAHR5542S2024-10-31
08800023142501Link AbutmentICLAHR5543S2024-10-31
08800023142518Link AbutmentICLAHR5544S2024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
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00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29