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510(k) K121545

BELLYBOARD, SBRT ACCESSORIES by Medtec Inc. Dba Civco Medical Solutions — Product Code LNH

K121545 is an FDA 510(k) premarket notification submitted by Medtec Inc. Dba Civco Medical Solutions for the device "BELLYBOARD, SBRT ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 8, 2012. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medtec Inc. Dba Civco Medical Solutions has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2012
Date Received
May 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Medtec Inc. Dba Civco Medical Solutions

  • K182079 — Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Ther (September 7, 2018)

Other clearances for product code LNH

  • K260113 — uMR Astra (May 22, 2026)
  • K253862 — APERTO Lucent MRI System (April 6, 2026)
  • K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (March 27, 2026)
  • K260746 — S-scan Open (100001800) (March 27, 2026)
  • K251937 — nordicAudio (1.0) (March 20, 2026)
  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K253413 — LiverMultiScan (v6.0) (March 9, 2026)
  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)

FDA data resources