Identity
- Trade Name
- DEXIS 10 (DEXIS Imaging Suite) FDA UDI
- Generic Name
- Radiology information system application software FDA UDI
- Model / Reference
- 10 FDA UDI
Identifiers
- Catalog Number
- 1.008.7934 FDA UDI
- Primary DI / UDI-DI
- EKAV100879340 FDA UDI
- 510(k) Number
- K090431 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology information system application software
DEXIS 10 (DEXIS Imaging Suite) by Dexis Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology information system application software.
- Orpheus CAST App — ORPHEUS MEDICAL LTD · Class II
- eRAD RIS — Erad, Inc. · Class II
- RamSoft — Ramsoft Inc · Class II
- Roentgen Works — BRIT SYSTEMS · Class II
- Pre-Sure — Lazarus 3D · Class II
- Gendex VixWin™ imaging software — GENDEX CORP. · Class II
- InvivoMac — ANATOMAGE, INC. · Class II
- Roentgen Works — BRIT SYSTEMS · Class I
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dexis Llc
Sources (1)
- FDA UDI 2833d196-ac29-44a1-9768-90dfc50fa217 34 fields · synced Jun 8, 2026