Primary Device ID | 00198953030233 |
NIH Device Record Key | a5c26931-6ec5-4eb7-b20c-ec676aea1478 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Caption |
Version Model Number | AI |
Company DUNS | 119309548 |
Company Name | Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00198953030233 [Primary] |
QIH | Automated Radiological Image Processing Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-05 |
Device Publish Date | 2025-07-28 |
00198953001073 - Venue | 2025-08-08 Venue R6 final Assembly |
00198953001097 - Venue Go | 2025-08-08 Venue Go R6 Final Assembly |
00198953001103 - Venue Fit | 2025-08-08 Venue Fit R6 Final Assembly |
00198953001387 - Venue Sprint | 2025-08-08 Venue Sprint R6 MD |
00198953030233 - Caption | 2025-08-05Caption AI on Vscan |
00198953030233 - Caption | 2025-08-05 Caption AI on Vscan |
00195278756138 - Invenia | 2025-03-20 Invenia ABUS Prime |
00195278756237 - Invenia | 2025-03-12 Invenia ABUS Premium |
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