Identity
- Trade Name
- INTRABEAM SMART Stand FDA UDI
- Generic Name
- Intraoperative/postoperative therapeutic x-ray system FDA UDI
- Device Name
- The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site. FDA UDI
- Model / Reference
- 6650 FDA UDI
- Description
- The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539066503 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 SMART Stand 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® 600 — Carl Zeiss Meditec AG · Class II
- INTRABEAM® PRS 500 — Carl Zeiss Meditec AG · Class II
- INTRABEAM — 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 — Carl Zeiss Meditec AG
- 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 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 1512b33e-60e9-4a45-a0fd-9ba751e78646 34 fields · synced May 30, 2026