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Acutscan Model 100 MRI System

by Palomex Instrumentarium Corp.

PMA P860010

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P860010↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP860010 Date22 Apr 1987ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
System, nuclear magnetic resonance imaging
PMA Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
APPR Approved
PMA Supplement
S001 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Acutscan Model 100 MRI System is a nuclear magnetic resonance imaging system designed for radiologic imaging. It generates detailed images of internal body structures using strong magnetic fields and radio waves, enabling diagnostic evaluation of soft tissues, organs, and musculoskeletal systems.

This system is intended for use in clinical radiology settings and is supplied as a reusable medical device. It operates within MRI-safe environments and requires specialized installation and maintenance. The device holds an FDA Premarket Approval (PMA) under the classification of Class II (LNH), with PMA number P860010 and subsequent supplements. No additional regulatory status beyond the stated PMA is implied.

Other devices from Palomex Instrumentarium Corp.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Acutscan Model 100 MRI System?

    The Acutscan Model 100 MRI System is designed for radiologic imaging, generating detailed images of internal body structures using strong magnetic fields and radio waves to enable diagnostic evaluation of soft tissues, organs, and musculoskeletal systems.

  • Is the Acutscan Model 100 MRI System a single-use or reusable device?

    The Acutscan Model 100 MRI System is supplied as a reusable medical device intended for use in clinical radiology settings, requiring specialized installation and maintenance.

  • What regulatory approval does the Acutscan Model 100 MRI System hold?

    The Acutscan Model 100 MRI System holds an FDA Premarket Approval (PMA) under the classification of Class II (LNH), with PMA number P860010 and subsequent supplements.

  • What are the environmental requirements for operating the Acutscan Model 100 MRI System?

    The Acutscan Model 100 MRI System operates within MRI-safe environments and requires specialized installation and maintenance to ensure proper functioning and safety.