FDA.reportPublic FDA data

THD Procto Software System

Primary DI
18033737712341
Brand
THD Procto Software System
Company
THD SPA
Model
THD 4K CAM
Catalog number
800195
Device description
THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve.Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera.
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWGCamera, Television, Endoscopic, With Audio
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
KLAMonitor, Esophageal Motility, And Tube
NSXSoftware, Transmission And Storage, Patient Data
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWGCamera, Television, Endoscopic, With AudioGeneral, Plastic Surgery1
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology2
NSXSoftware, Transmission And Storage, Patient Data
OUGMedical Device Data SystemGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211623000THD Procto Software SystemThd Spa2021-06-24IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033737712341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803373771234118033737712341

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program 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

Contacts#

Phone, Email table
PhoneEmail
+390522634311regulatory@thdlab.com

Regulatory Flags#

DUNS number
338430324
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033737710777THD SLIDE ONETHD OPTI-FIBER (REVO/BT)8800122022-09-01
18033737710781THD SLIDE ONETHD OPTI-FIBER (EVO/BT)8800182022-09-09
08051887049837THD BIOPSYTHD BIOPSY (GI)8003002026-01-07
08051887049851THD BIOPSYTHD BIOPSY (J)8003172026-01-07
08051887049875THD BIOPSYTHD BIOPSY (GI - XL)8003282026-01-07
18051887049841THD BIOPSYTHD BIOPSY (GI)8003002026-01-07
18051887049865THD BIOPSYTHD BIOPSY (J)8003172026-01-07
18051887049889THD BIOPSYTHD BIOPSY (GI - XL)8003282026-01-07
08033737710869THD SLIDE ONETHD SLIDE7100042025-10-30
18033737710354THD SLIDE ONETHD DOPPLER PROBE (1s/ST)8000632025-10-30
08051887047918THD SLIDE ONETHD ANOLIFT US8003302025-04-03
18051887047915THD SLIDE ONETHD ANOLIFT US8003302025-04-03
08051887044719THD N-Ano anoscopesTHD N-ANO DIGITAL (TR)8003132025-03-14
08051887044733THD N-Ano anoscopeTHD N-ANO DIGITAL (BE)8003142025-03-14
08051887044757THD N-Ano AnoscopeTHD N-ANO DIGITAL MAXI (TR)8003152025-03-14
08051887044771THD N-ano anoscopeTHD N-ANO DIGITAL MAXI (BE)8003162025-03-14
18051887044716THD N-Ano anoscopesTHD N-ANO DIGITAL (TR)8003132025-03-14
18051887044730THD N-Ano anoscopeTHD N-ANO DIGITAL (BE)8003142025-03-14
18051887044754THD N-Ano AnoscopeTHD N-ANO DIGITAL MAXI (TR)8003152025-03-14
18051887044778THD N-ano anoscopeTHD N-ANO DIGITAL MAXI (BE)8003162025-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23