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510(k) K081118

NORAS MR-BI320-PA 1.5T by Noras Mri Products GmbH — Product Code MOS

K081118 is an FDA 510(k) premarket notification submitted by Noras Mri Products GmbH for the device "NORAS MR-BI320-PA 1.5T". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Noras Mri Products GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
April 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Noras Mri Products GmbH

  • K241069 — iLoop Interventional Coil 0.55T (June 7, 2024)
  • K220144 — Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set (April 8, 2022)
  • K211658 — OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with Head (March 3, 2022)
  • K180123 — Breast BI 7 MR Coil 1.5T Mammavention (February 16, 2018)
  • K133506 — NORAS OR HEAD HOLDER FLEXIBILITY (August 6, 2014)
  • K093693 — NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 72 (January 19, 2010)
  • K091546 — NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 (June 24, 2009)
  • K083578 — NORAS CPC MULTIFUNCTIONAL COIL (January 16, 2009)
  • K082373 — NORAS MR-BI320-PA 3T (August 29, 2008)

Other clearances for product code MOS

  • K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Bre (July 30, 2026)
  • K262294 — dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS H (July 24, 2026)
  • K260947 — 0.55T 12Ch Breast Coil (April 23, 2026)
  • K252587 — HD 8Ch Wrist Array (April 14, 2026)
  • K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Rece (April 1, 2026)
  • K260519 — Smart Fit TorsoCardiac 1.5T (March 20, 2026)
  • K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Rece (February 10, 2026)
  • K253738 — 3.0T AIR 32CH HNA (January 23, 2026)
  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)

FDA data resources