FDA.reportPublic FDA data

AcQMap

Primary DI
00857042007999
Brand
AcQMap
Company
ACUTUS MEDICAL, INC.
Model
900000
Catalog number
900000
Device description
AcQMap System
Published
2022-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857042007999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857042007999008570420079998570420079990857042007999

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping systemAn assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(442)232-6100product.complaints@acutus.com

Regulatory Flags#

DUNS number
844418199
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850027837666AcQGuide MAX900200-003900200-0032023-08-30
00857042007906AcQGuide VUE9002019002012022-05-13
00850027837017AcQGuide MAX9002009002002021-10-08
00857042007432AcQGuide1128522019-07-24
00857042007456AcQGuide1228521228522019-07-24
00857042007012AcQGuide9000029000022018-02-15
00850027837253DiamondTemp Generator Adapter8007278007272022-10-24
00850027837635DiamondTemp Generator Adapter8008188008182022-10-24
00850027837642StabilICE9002219002212022-04-01
00850027837659StabilICE9002189002182022-04-01
00850027837192AcQMap8006988006982022-02-01
00850027837222AcQMap8006958006952022-02-01
00850027837239AcQMap8006968006962022-02-01
00850027837246AcQMap8006978006972022-02-01
00850027837444AcQMap8007108007102022-02-01
00850027837451AcQMap8007398007392022-02-01
00850027837468AcQMap8007428007422022-02-01
00850027837475AcQMap8007458007452022-02-01
00850027837482AcQMap8007488007482022-02-01
00857042007333AcQMap8006018006012022-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21