Identity
- Trade Name
- PacScan Plus EUDAMEDPacScan 300 Plus Ophthalmic Ultrasound FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- PacScan Plus Ophthalmic Ultrasound EUDAMEDThe PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The PacScan 300A+ system includes a 6" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, foot switch and operator manual. FDA UDI
- Model / Reference
- 300 A+ EUDAMED300A+ EUDAMED300A+ A-Scan Only FDA UDI
- Description
- The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The PacScan 300A+ system includes a 6" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, foot switch and operator manual. FDA UDI
Identifiers
- Catalog Number
- 300A+ FDA UDI
- Primary DI / UDI-DI
- 00896100002088 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00896100002088 EUDAMED
- 510(k) Number
- K092637 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PacScan Plus by Sonomed, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00896100002088 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonomed, Inc.
- EUDAMED SRN
- US-MF-000002342
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED eccc8317-e9c8-490f-a1cb-2693924e33f7 61 fields · synced Jul 11, 2026
- FDA UDI 0c30b0d4-51fc-4ce2-8601-d7de58280888 36 fields · synced May 25, 2026