Identity
- Trade Name
- NOVAC11 FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known as Intraoperative Radiation Therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues. The NOVAC 11 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. FDA UDI
- Model / Reference
- 10 MeV FDA UDI
- Description
- The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known as Intraoperative Radiation Therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues. The NOVAC 11 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. FDA UDI
Identifiers
- Catalog Number
- N300000-01-03 FDA UDI
- Primary DI / UDI-DI
- 08057014730487 FDA UDI
- 510(k) Number
- K112286 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Linear accelerator system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Linear accelerator system
Novac11 by Sit Sordina Iort Technologies Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Linear accelerator system.
- SW, Legal Labelling Install Disk, 5.1.9 — Accuray Incorporated · Class II
- Radixact®, Treatment Delivery Console (TDC) — Accuray Incorporated · Class II
- Radixact®, Treatment Delivery Console — Accuray Incorporated · Class II
- Clinac iX — Varian Medical Systems, Inc · Class II
- TomoHDA® Treatment Delivery System — Accuray Incorporated · Class II
- reNEW™ Certified Pre-Owned System — Accuray Incorporated · Class II
- CyberKnife® M6™ Systems — Accuray Incorporated · Class II
- Head Coil (Receive Only) — VIEWRAY INCORPORATED · Class II
Cleared under the same submission
K112286 also covers:
- ABSORBER SHIELD — Sit Sordina Iort Technologies Spa
- ABSORBER SHIELD — Sit Sordina Iort Technologies Spa
- ABSORBER SHIELD — Sit Sordina Iort Technologies Spa
- ABSORBER SHIELD — Sit Sordina Iort Technologies Spa
- ABSORBER SHIELD — Sit Sordina Iort Technologies Spa
- ABSORBER SHIELD — Sit Sordina Iort Technologies Spa
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
- Sit Sordina Iort Technologies Spa
Sources (1)
- FDA UDI a15f6a58-465c-4fdb-b1da-64dd0ab00ea0 38 fields · synced May 30, 2026