Identity
- Trade Name
- DYONICS FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- DYONICS PLAN 90DAY LICENSE FDA UDI
- Model / Reference
- 72204332 FDA UDI
- Description
- DYONICS PLAN 90DAY LICENSE FDA UDI
Identifiers
- Catalog Number
- 72204332 FDA UDI
- Primary DI / UDI-DI
- 00885556604168 FDA UDI
- 510(k) Number
- K132636 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Image segmentation 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Image segmentation application software
Dyonics by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Image segmentation application software.
- BrainInsight — Hyperfine Operations, Inc. · Class II
- Neosoma Glioma — Neosoma, Inc. · Class II
- Iris — Intuitive Surgical, Inc. · Class II
- inHEART MODELS Shaper — INHEART · Class II
- Preview — GENESIS SOFTWARE INNOVATIONS · Class II
- Neosoma Dashboard — Neosoma, Inc. · Class II
- ProVoyance PreOp Shoulder — GENESIS SOFTWARE INNOVATIONS · Class II
- ClearPoint Maestro — Clearpoint Neuro, Inc. · Class II
Cleared under the same submission
K132636 also covers:
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 3fd9cb17-7fb4-4371-8ccd-f9673b9f2ebd 36 fields · synced Jun 8, 2026