FDA.reportPublic FDA data

IMAGE DIAGNOSTICS, INC

Primary DI
00850061871091
Brand
IMAGE DIAGNOSTICS, INC
Company
IMAGE DIAGNOSTICS, INC.
Model
FEMORAL SHIELD RADIATION SHIELD PAD
Catalog number
X800-0251
Device description
IDI,PROTEGO,PAD,SCATTER SHIELD,FEMORAL,CASE OF 15,#X800-0251
Published
2024-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061871107PrimaryGS10
00850061871091Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061871107008500618711078500618711070850061871107
00850061871091008500618710918500618710910850061871091

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
608235214
Device count
15
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00850061871213IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871220IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871237IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
20748426261936Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261950Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143457Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143495Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143061Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143412Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143481Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426144280Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143078Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
00748426143467DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143471DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
10748426144270DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143443DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00816611026052Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30
00816611026069Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30