FDA.reportPublic FDA data

3D-RD-S

Primary DI
00860009926905
Brand
3D-RD-S
Company
Radiopharmaceutical Imaging and Dosimetry, LLC
Model
3DRD-001
Device description
The device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Published
2023-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYXCamera, Scintillation (Gamma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYXCamera, Scintillation (Gamma)Radiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2125870003D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLC2023-02-22IYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009926905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009926905008600099269058600099269050860009926905

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine system workstationA freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4435247396info@rapoiddosimetry.com
4435247396support@rapoiddosimetry.com

Regulatory Flags#

DUNS number
080200015
Device count
1
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859873006219Hermia OLINDAHermes Medical Solutions ABIYX2026-03-10
00810149098215R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-12-15
00810149098116R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-10-15
B843UNISYN7510UniSynConvergent Imaging Solutions IncorporatedIYX2025-08-20
00810149098000R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-07-14
00810149097966R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-05-22
00810149097928R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-03-04
00810149097799R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097836R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097843R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097737R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-29
00810149097713R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-14
00810149097706R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-07
00810149097683R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097690R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097638R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-05
00810149097621R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-04
00810149097607R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-22
00810149097584R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-17
00810149097546R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-12
00810149097522R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-06
00810149097409R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-08-09
00810149097287R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-06-18
00810149097270R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-04-15
00810149097263R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-03-05
00810149090073R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090141R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090158R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090196R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090202R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01