FDA.reportPublic FDA data

NA

Primary DI
00840682138291
Brand
NA
Company
USA INSTRUMENTS, INC.
Model
MEDIAL LARGE GRID BREAST BIOPSY PLATE
Published
2017-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041695000LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATEUsa Instruments, Inc.2004-07-23LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682138291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682138291008406821382918406821382910840682138291

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

Regulatory Flags#

DUNS number
804517571
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
001989530019981.5T AIR Posterior Array601510060151002025-12-10
00840682120050NA53914682016-08-01
00840682120067NA53928022016-08-01
00840682103732NA3.0T HD SHOULDER ARRAY24143312016-08-01
00840682103756NA3.0T HD BREAST ARRAY24155442016-08-01
00840682103763NA3.0T HD FLAT GEM TABLE BREAST ARRAY53974742016-08-01
00840682104487NA3.0T HD 8CH CTL ARRAY24155422016-08-01
00840682108560NA3.0T GEM RT Open Array2016-08-01
00840682108577NA3.0T GEM PVA53952552016-08-01
00840682108614NA3.0T 8CH HD TORSO ARRAY24154102016-08-01
00840682109741NA3.0T GEM HNU54450512016-08-01
00840682116473NA3.0T HD 8CH CARDIAC ARRAYU1-1004222016-08-01
00840682121033NACARDIAC ARRAY 1.5T 51546852016-08-01
00840682102483NA3.0T GEM Anterior Array53914542016-08-01
00840682104470NA3.0T HD NEUROVASCULAR ARRAY2016-08-01
00840682105095NA3.0T GEM PA53929302016-08-01
00840682108881NA3.0T AA55551672016-08-01
00840682114264NA3.0T 16CH HEAD NECK SPINE HNS ARRAY53413332016-08-01
00195278665249NA48CH HEAD COIL - 593010059301002023-08-03
00195278575814NA3.0T 16ch AIR AA58541012023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19