FDA.reportPublic FDA data

DaTQUANT

Primary DI
00840682119306
Brand
DaTQUANT
Company
G E MEDICAL SYSTEMS ISRAEL LTD.
Model
1.0
Published
2016-09-05
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
LLZSystem, image processing, radiological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130884000XELERIS 3.1 PROCESSING AND REVIEW WORKSTATIONGe Medical Systems F.I. Haifa2013-04-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682119306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682119306008406821193068406821193060840682119306

GMDN Terms#

Term, Definition table
TermDefinition
SPECT system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a single photon emission computed tomography (SPECT) imaging system configuration. A basic set of applications programs and routines is included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some packages must be combined with specific hardware or firmware 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

Regulatory Flags#

DUNS number
532102365
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953246405Xeleris V Processing and Review System5.160150872026-08-03
00195278118295StarGuideH3911AB2021-05-10
00195278011343DaTQUANT2.02020-06-16
00840682122771Vividi-q-S5-S6 BT12 UPG2017-01-19
00195278614933Xeleris Processing and Review WorkstationV59279112025-10-31
00195278822383Xeleris Processing and Review WorkstationV2025-10-31
00198953061329NMCT 860H3908BJ, H3908BH2025-09-09
00198953061336NMCT 850H3907BE, H3907BF2025-09-09
00195278878502AuroraSPECT with Revolution Ascend CT2025-02-25
00195278870490StarGuide MDD to MDR Upgrade596242659624262024-05-16
00195278755544StarGuideH3911BJ5842898-102024-04-18
00195278794772D630 to D670 DR UpgradeH3101RS59530352024-03-18
00195278788252NM8305376204-332023-11-15
00195278788269NMCT870 DR2023-11-14
00195278488619MyoSPECTH3912BC5875815-302023-09-14
00195278488626MyoSPECT ESH3912BD5875815-402023-09-14
00195278722546MyoSEPCT ES to MyoSPECT UpgradeH3912BS59414452023-09-14
00195278592309OmniLegend2022-09-12
00195278421579MyoSPECT ESH3912AB5875815-202021-10-11
00195278421586MyoSPECTH3912AA5875815-102021-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
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
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01