Manufacturer profile
Digital Imaging Systems
Manufacturer snapshot
Overview of registrations for this manufacturer
20
Total Registrations
20
Distinct Products
7/10/2023
Latest Registration
5/18/2022
Earliest
Risk class distribution
Risk B6
Risk D12
Risk C2
Registrations (20)
Click a registration number to view details
Intrasight
Cardiovascular
Ultrasound Imaging
System
[797403]7/10/2023
Registration: MDIR-0005299
Risk Class: B
Expires: 7/9/2028
Refinity ST
Intravascular
Ultrasound Imaging
Catheter
[89900]7/10/2023
Registration: MDIR-0005301
Risk Class: B
Expires: 7/9/2028
Intrasight Mobile
System
Cardiovascular
Ultrasound Imaging
System
[797415]7/10/2023
Registration: MDIR-0005298
Risk Class: B
Expires: 7/9/2028
Omniwire Pressure
Guidewire
Transducer, pressure,
Catheter tip
[89185, 89185J]7/10/2023
Registration: MDIR-0005302
Risk Class: B
Expires: 7/9/2028
Syncvision System
Cardiovascular
Ultrasound Imaging
System
[400-0100.10]7/10/2023
Registration: MDIR-0005300
Risk Class: B
Expires: 7/9/2028
HI-TORQUE
Proceed Guide Wire4/3/2023
Registration: MDIR-0004990
Risk Class: B
Expires: 4/2/2028
Pacel Flow Directed
Pacing Catheter3/9/2023
Registration: MDIR-0004915
Risk Class: D
Expires: 3/8/2028
Pacel Bipolar Pacing
Catheter3/9/2023
Registration: MDIR-0004914
Risk Class: D
Expires: 3/8/2028
Eagle Eve Platinum
Digital and Short Tip
IVUS Catheter
(Intravascular
Ultrasound Imaging
Catheter)
[85900P-85900PST]2/6/2023
Registration: MDIR-0004608
Risk Class: D
Expires: 2/5/2028
Amplatzer Talisman
PFO Occluder7/4/2022
Registration: MDIR-0003530
Risk Class: D
Expires: 7/3/2027
Amplatzer Amulet
Delivery Sheath7/4/2022
Registration: MDIR-0003531
Risk Class: D
Expires: 7/3/2027
Hi- Torque Turn Trac
Flex Guide Wire7/4/2022
Registration: MDIR-0003532
Risk Class: D
Expires: 7/3/2027
Amplatzer Talisman
Delivery Sheath7/4/2022
Registration: MDIR-0003533
Risk Class: D
Expires: 7/3/2027
GRAFTMASTER RX
Coronary Stent Graft
System6/9/2022
Registration: MDIR-0003421
Risk Class: D
Expires: 6/8/2027
Xience Alpine
Everolimus Eluting
Coronary Stent
System6/9/2022
Registration: MDIR-0003420
Risk Class: D
Expires: 6/8/2027
Absolute Pro
Peripheral
Self-Expanding Stent
System6/9/2022
Registration: MDIR-0003418
Risk Class: C
Expires: 6/8/2027
Absolute Pro LL
Peripheral
Self-Expanding Stent
System6/9/2022
Registration: MDIR-0003419
Risk Class: C
Expires: 6/8/2027
Amplatzer Valvular
Plug III (occlusion
device)
[9-APVL3-042,
9-APVL3-063,
9-APVL3-084,
9-APVL3-103,
9-APVL3-105,
9-APVL3-123,
9-APVL3-125,
9-APVL3-143,
9-APVL3-145]5/19/2022
Registration: MDIR-0003389
Risk Class: D
Expires: 5/18/2027
Amplatzer Piccolo
Occluder5/18/2022
Registration: MDIR-0003384
Risk Class: D
Expires: 5/17/2027
Mitra Clip G4 System
[Steerable Guide
Catheter]
[SGC0705]5/18/2022
Registration: MDIR-0003383
Risk Class: D
Expires: 5/17/2027
About this profile
Access the DRAP portfolio for Digital Imaging Systems via Pure Global AI. This manufacturer holds 20 registrations across 20 distinct products, with registrations ranging from 5/18/2022 to 7/10/2023 and spanning 3 risk classes.
This mirrors the Brazil holder experience with a concise snapshot and direct links to each DRAP registration.
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