FDA.reportPublic FDA data

Echo-Flex 5002

Primary DI
00670482001071
Brand
Echo-Flex 5002
Company
Umano Medical Inc
Model
903-0000
Device description
Powered table for ultrasound procedure and patient exam.
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00670482001071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00670482001071006704820010716704820010710670482001071

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose diagnostic imaging tableAn electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
249675476
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670482001101oneNEST S303-804208HS4FB-BIL2026-07-31
00670482001118oneNEST S303-844208HS4FB-BIL2026-07-31
00670482001125oneNEST M303-M804208HS2FB-BIL2026-07-31
00670482001132oneNEST M303-M844208HS2FB-BIL2026-07-31
00670482001019oneNEST M303-M803508HS2FB-BIL2026-04-24
00670482001026oneNEST M303-M843508HS2FB-BIL2026-04-24
00670482000982Umano Connect282-0002282-00022025-08-04
00670482000920ook snowFL36 ook snowFL362025-05-16
00670482000944ook cocoonFL36 ook cocoonFL362025-05-16
00670482000951ook snow ALL200-0000200-00002025-05-16
10670482000927ook snowFL36 ook snowFL362025-05-16
00670482000937ook snow MHFL36 ook snow MHFL36 ook snow MH2025-05-16
10670482000941ook cocoonFL36 ook cocoonFL362025-05-16
10670482000958ook snow ALL200-0000200-00002025-05-16
00670482000463Freedom 500FM500FM5002021-02-05
00670482000487Freedom 1000FM1000FM10002021-06-04
00670482000470Freedom 1000FM1000FM10002021-02-05
00670482000838Patient Helper 299-0100WG-TRI299-0100WG-TRI2024-09-17
00670482000845REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64511-TRIFA64511-TRI2024-09-17
00670482000852REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64509-TRIFA64509-TRI2024-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00667259004007Laguna Edge (2M)Silhouet-Tone CorporationLGX2025-11-12
00728564057000Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564057017Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564058007Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564058014Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060000Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564065005Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564065012Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564068006Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564068013Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564157007Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564157014Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158004Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160014Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564165002Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564165019Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564168003Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564168010Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00613647029268FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LGX2025-04-30