Identity
- Trade Name
- INTRABEAM FDA UDI
- Generic Name
- Intraoperative/postoperative therapeutic x-ray system FDA UDI
- Device Name
- The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment. It is intended to deliver, monitor, and report a radiation therapy treatment. FDA UDI
- Model / Reference
- 700 FDA UDI
- Description
- The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment. It is intended to deliver, monitor, and report a radiation therapy treatment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539064080 FDA UDI
- 510(k) Number
- K241174 FDA UDI
- FDA Product Code
- JAD FDA UDI
- GMDN Term
- Intraoperative/postoperative therapeutic x-ray system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5900 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: Intraoperative/postoperative therapeutic x-ray system
Intrabeam by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative/postoperative therapeutic x-ray system.
- INTRABEAM SMART Stand — Carl Zeiss Meditec AG · Class II
- INTRABEAM® 600 — Carl Zeiss Meditec AG · Class II
- INTRABEAM® PRS 500 — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Cart — Carl Zeiss Meditec AG · Class I
- NC32 INTRABEAM® Floor Stand — Carl Zeiss Meditec AG · Class I
Cleared under the same submission
K241174 also covers:
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (35 mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (35mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (40mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (45mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Stand — Carl Zeiss Meditec AG
- INTRABEAM Spherical Sizer Set — Carl Zeiss Meditec AG
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 |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 66a2af8b-6b5b-497b-a97f-d6f29dde1af8 34 fields · synced May 30, 2026