BrightMatter Plan

Primary DI
00670082000160
Brand
BrightMatter Plan
Company
Synaptive Medical Inc
Model
1.4
Catalog number
SYN-0004
Published
2016-11-11
Public version status
Update
Distribution status
Not 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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140337000BRIGHTMATTER PLANNING SOFTWARESynaptive Medical, Inc.2014-06-02LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00670082000160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00670082000160006700820001606700820001600670082000160

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
203061833
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
00670082000610Modus Plan2.2SYN-08662025-01-17
00670082000511Modus Plan2.1SYN-08662022-12-13
00670082000443Modus Plan2.0SYN-08662019-08-06
00670082000085BrightMatter Plan1.3SYN-00042016-09-24
00670082000115ImageDrive Clinical1.1SYN-05782016-09-24
00670082000122ImageDrive Pro1.1SYN-06272017-08-16
00670082000139ClearCanvas Personal Edition Workstation13.1SYN-05242017-08-16
00670082000368BrightMatter Plan1.5SYN-00042018-09-28
00670082000412BrightMatter Plan1.6SYN-08662018-09-28
00670082000153Trackable Suction - Tube 6-L-30SYN-06512017-02-28
00670082000214Trackable Suction - Tube 12-L-30SYN-06532017-02-28
00670082000221Trackable Suction - Tube 6-L-90SYN-06542017-02-28
00670082000238Trackable Suction - Tube 10-L-90SYN-06552017-02-28
00670082000245Trackable Suction - Tube 12-L-90SYN-06562017-02-28
00670082000276Trackable Suction - Tube 4-S-30SYN-06712017-06-30
00670082000283Trackable Suction - Tube 6-S-30SYN-06722017-06-30
00670082000290Trackable Suction - Tube 8-S-30SYN-06732017-06-30
00670082000306Trackable Suction - Tube 10-S-30SYN-06742017-06-30
00670082000313Trackable Suction - Tube 4-M-30SYN-06752017-06-30
00670082000320Trackable Suction - Tube 6-M-30SYN-06762017-06-30

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Primary DI, Brand, Company table
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00198715251623BrainSpec Coreā„¢ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
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00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
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