FDA.reportPublic FDA data

IMAGE DIAGNOSTICS INC

Primary DI
00850977007010
Brand
IMAGE DIAGNOSTICS INC
Company
IMAGE DIAGNOSTICS, INC.
Model
100UC Plus
Catalog number
A100-2639
Device description
IDI,TABLE,VERT.-TILT-HORIZ. TABLETOP MOVEMENT,UROLOGY & IMAGING,ASPECT 100UC PLUS,230V,METRIC ACC'Y RAILS,#A100-2639
Published
2017-09-18
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
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850977007010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850977007010008509770070108509770070100850977007010

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose diagnostic imaging tableAn electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-978-829-0009rrossi@imagediagnostics.com

Regulatory Flags#

DUNS number
608235214
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850061871213IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR 22IN WIDE TABLEA610-0922026-02-24
00850061871220IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR 24IN WIDE TABLEA610-0962026-02-24
00850061871237IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR 28IN WIDE TABLEA610-1082026-02-24
00850061871459IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR ISO-DRIVE FACIAA610-4072026-02-24
00850061871398IMAGE DIAGNOSTICS, INCARTICULATING RADIATION SHIELD FOR U.S. ACCY RAILSA610-0512026-01-30
00850061871404IMAGE DIAGNOSTICS, INCARTICULATING RADIATION SHIELD FOR METRIC ACCY RAILA610-1062026-01-30
00850061871411IMAGE DIAGNOSTICS, INCFIXED RADIATION SHIELD FOR TABLE TOP MOUNTA610-0802026-01-30
00850061871442IMAGE DIAGNOSTICS, INCProtego AFCM System for Philips Tables & SKYTRON bA800-0532-PH012026-01-20
00850061871381IMAGE DIAGNOSTICS, INCProtego Mobile BarrierA800-01552025-12-09
00850061871152IMAGE DIAGNOSTICS, INCProtego FCM System for Philips TablesA800-0250-PH012025-04-07
00850061871374IMAGE DIAGNOSTICS INCMONITOR CART,IDI W/27IN TOUCH MONITOR,GE OEC ONEA280-16272025-11-18
00850061871114IMAGE DIAGNOSTICS, INCUrology Drain Bag, SterileC000-05932025-10-28
00850977007959IMAGE DIAGNOSTICS INC100UC+A100-30992025-08-07
00850061871268IMAGE DIAGNOSTICS, INC.ILEX DUO DIRECT CONNECT 27A280-15672025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.ILEX DUO DIRECT PREMIUM 32A280-15682025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.ILEX DUO PLATINUM 32A280-15692025-07-14
00850061871367IMAGE DIAGNOSTICS, INCCompass Contour Suspended System with 1 ArmA610-0211-1302025-07-07
00850061871299IMAGE DIAGNOSTICS, INCProtego MRS System for GE Table Tops w/Metric AcceA800-0002-GE022025-07-02
00850061871305IMAGE DIAGNOSTICS, INCProtego MRS System for Large Table Tops w/Metric AA800-0004-SAI022025-07-02
00850061871312IMAGE DIAGNOSTICS, INCProtego MRS System for Large Table Tops w/Metric AA800-0004-SII012025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841736125271SkytronSKYTRON LLCMMZ2026-05-01
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
07350006950070Sonesta P3Sonesta Medical ABMMZ2025-09-30
07350006950087Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950094Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950117Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950124Sonesta P3Sonesta Medical ABMMZ2025-09-30
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
00817463026429Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026306Oakworks MedicalOAKWORKS, INC.MMZ2023-07-17
00817463026245Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026030Oakworks MedicalOAKWORKS, INC.MMZ2023-06-29
00618125139989TIDITIDI PRODUCTS, LLCMMZ2022-09-29
00618125140008TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157679Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157686Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125139986TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140005TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140081TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157447DASSETIDI PRODUCTS, LLCMMZ2022-09-29
10618125157676Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157683Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157966Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29