FDA.reportPublic FDA data

Breast Imaging Accessory

Primary DI
00850816007195
Brand
Breast Imaging Accessory
Company
DIGIRAD CORPORATION
Model
BIA
Published
2016-09-12
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850816007195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850816007195008508160071958508160071950850816007195

GMDN Terms#

Term, Definition table
TermDefinition
Radiological breast positioner, non-wearableA device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8587261600callcenter@digirad.com

Regulatory Flags#

DUNS number
148548738
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850816007027LEHR Collimator LEHR2016-09-12
00850816007034Cardius 2XPOD2016-09-09
00850816007041Cardius 2Mobile XPOD2016-09-09
00850816007058Cardius 2XPOD International2016-09-09
00850816007065Cardius 2Mobile XPOL2016-09-09
00850816007072Cardius 3XPOD2016-09-09
00850816007089Cardius 3Mobile XPOD2016-09-09
00850816007096Cardius 1Mobile2016-09-09
00850816007102Cardius X-ActDomestic2016-09-09
00850816007119Cardius X-ActInternational2016-09-09
00850816007126LEAP CollimatorLEAP2016-09-12
00850816007133MEAP CollimatorMEAP2016-09-12
00850816007140PINHOLE CollimatorPINHOLE 2016-09-12
00850816007157Diverging CollimatorDiverging2016-09-12
00850816007164Mamo CollimatorMamo2016-09-12

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