BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC

System, Nuclear Magnetic Resonance Imaging

NORAS RONTGEN-UND MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Noras Rontgen-und Medizintechnik Gmbh with the FDA for Breast Immobilization And Biopsy Device, Models Bi 160-o, Bi 160-pa And Bi 160-cc.

Pre-market Notification Details

• Device ID: K052987
• 510k Number: K052987
• Device Name: BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: NORAS RONTGEN-UND MEDIZINTECHNIK GMBH 1600 MANCHESTER WAY Corinth, TX 76210
• Contact: Carl Alletto
• Correspondent: Carl Alletto; NORAS RONTGEN-UND MEDIZINTECHNIK GMBH 1600 MANCHESTER WAY Corinth, TX 76210
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-24
• Decision Date: 2005-11-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04251269203404	K052987	000
04251269203398	K052987	000
04251269202520	K052987	000
04251269202513	K052987	000
04251269202506	K052987	000
04251269202490	K052987	000
04251269202469	K052987	000
04251269205729	K052987	000