FDA.report

aprevo

Primary DI
00810056991357
Brand
aprevo
Company
Carlsmed, Inc.
Model
5004
Device description
aprevo, Digital Segmentation
Published
2026-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications

CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions

SubmissionSupplement
K231955000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231955000aprevo® Digital SegmentationCarlsmed, Inc.2023-11-03QIH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810056991357PrimaryGS10

GMDN Terms

TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods

Method

Regulatory Flags

DUNS number
117449452
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810056992743aprevo1098.13.22026-03-17
00810056992804aprevo1098.15.22026-03-17
00810056992866aprevo1098.17.22026-03-17
00810056992958aprevo1098.20.22026-03-17
00810056995430corra1426.18.32026-03-11
00081005699543corra1426.18.32026-02-04
00810056993092corra16102026-01-31
00810056993108corra16162026-01-30
00810056993122corra1550.27.142026-01-30
00810056993139corra15602026-01-30
00810056993146corra16202026-01-30
00810056993153corra1550.22.122026-01-30
00810056993160corra1550.22.142026-01-30
00810056993177corra1550.22.162026-01-30
00810056993184corra1550.22.182026-01-30
00810056993191corra1550.22.202026-01-30
00810056993207corra1550.27.122026-01-30
00810056993214corra1550.27.162026-01-30
00810056993221corra1550.27.182026-01-30
00810056993238corra1550.27.202026-01-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04068151020076syngo DynamicsSiemens Healthcare GmbHQIH2026-03-19
09369900000857SalixARTRYA USA INC.QIH2026-02-17
09369998252183SalixARTRYA USA INC.QIH2026-02-17
08720892617637LumiNE USAugmedIT B.V.QIH2026-02-13
00860009223660Neosoma Brain MetsNeosoma, Inc.QIH2026-02-10
00860010268087Segmentron ViewerDGNCT LLCQIH2026-01-29
06429810209054SMART PCFDDisior OyQIH2026-01-27
05070003179800CDM InsightsOXFORD BRAIN DIAGNOSTICS LTDQIH2026-01-26
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Terarecon Inc.QIH2026-01-23
08809944936220HERA Z30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-01-20
00198953109434LOGIQGE Ultrasound Korea Ltd.QIH2026-01-14
00884838129771LVivo View SelectionPhilips Ultrasound LLCQIH2025-12-18
00860003567944Second Opinion 3DPearl Inc.QIH2025-12-12
00860005586394Overjet CBCT AssistOverjet, Inc.QIH2025-12-12
03663999000436AutoDensityEOS IMAGINGQIH2025-12-09
04260729622006VELYS Traumametamorphosis GmbHQIH2025-12-01
00841517112424Sonosite PXFUJIFILM SONOSITE, INC.QIH2025-11-24
00860011384809ConstellationQ Bio, Inc.QIH2025-10-17
05430002070124FEopsFEopsQIH2025-09-25
E2472110100003A20VistaSoftDÜRR DENTAL SEQIH2025-09-22
04262352353517DS Core DiagnosisZetta25 AGQIH2025-09-05
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCQIH2025-08-29
04068151009460syngo.MI GeneralSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2025-08-13
04068151009453syngo.MM OncologySIEMENS MEDICAL SOLUTIONS USA, INC.QIH2025-08-11
06971576834204uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
06971576834228uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
06971576834259uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
03663999000412VEA AlignEOS IMAGINGQIH2025-08-01
00198953030233CaptionGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcQIH2025-07-28
03770019599112inHEART Models ExplorerINHEARTQIH2025-07-15