Brainlab Interface Rotating, with Marking 01
Brainlab Interface Rotating, with Marking 01 (113382) is a Class II device made by NORAS MRI products GmbH, cleared under FDA 510(k) K071179 on 13 Jun 2007 and listed in FDA GUDID since 13 Jul 2018 (UDI-DI 04251269204715), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04251269204715 | Date13 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071179 | Date13 Jun 2007 | StatusActive |
Official records
- AccessGUDID record 04251269204715
- FDA 510(k) database K071179
Across registries
- FDA 510(k) K071179 decided 13 Jun 2007 Active
- FDA GUDID UDI-DI 04251269204715 listed 13 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K071179
- Listed FDA GUDID 04251269204715
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Brainlab Interface Rotating, with Marking
- Generic name
- MRI system coil, radio-frequency
- Model / Ref / Catalog
- 01, 113382
- Primary DI / UDI-DI
- 04251269204715
- 510(k) Number
- FDA product code
- MOS
- GMDN term
- MRI system coil, radio-frequency
- Device class
- Class II
- Regulation number
- 892.1000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under MRI system coil, radio-frequency.
- Philips 4598-000-20661 by SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
- 1.5T 16ch AIR AA 7771502 by GE Healthcare Coils
- dS MSK S 1.5T by Philips Healthcare (Suzhou) Co., Ltd.
- 1.5T 12 Channel Body Array 5396151 by GE Healthcare Coils
- Philips dS Base 3.0T 459801290092 by Philips Ds North America LLC
- Philips 4522-133-17141 by SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
- 1.5T Receive-Only 16ch Flex SPEEDER Medium NC042200 by NEOCOIL, LLC
- Discovery MR750 3.0T Split Head Coil 5182872 by GE Medical Systems, LLC
- Philips dS FootAnkle 16Ch 3.0T 459801295501 by Philips Ds North America LLC
- dS TorsoCardiac 1.5T 459801681991 by Philips Healthcare (Suzhou) Co., Ltd.