AccessGUDID - DEVICE: Caption (00198953030233)

GUDID

Device Identifier (DI) Information

Brand Name: Caption
Version or Model: AI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Primary DI Number: 00198953030233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119309548 *Terms of Use

Device Description: Caption AI on Vscan

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIH	Automated Radiological Image Processing Software
QJU	Image Acquisition And/Or Optimization Guided By Artificial Intelligence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190040	000
DEN220063	000
K210747	000
K243065	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5c26931-6ec5-4eb7-b20c-ec676aea1478
Public Version Date: August 05, 2025
Public Version Number: 1
DI Record Publish Date: July 28, 2025