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Mimvista Corp.

United StatesFDA applicant, unverified

Devices
4
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Mimvista Corp. makes

Mimvista Corp. manufactures medical imaging software platforms designed for cardiac and neurological applications, including systems like the MIM 4.1 (SEASTAR) for cardiac electrophysiology planning, the MIM 3.5 (CIRCA) for cardiac resynchronization therapy, and the MIM 4.0 (NEURO) for neurosurgical and neurointerventional procedures. The company also provides the MIMVIEWER, a standalone tool for reviewing and analyzing medical imaging data.

These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance pathway. The company’s products are listed in the FDA’s 510(k) database, and Mimvista Corp. is headquartered in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Mim 4.1 (Seastar) Ref K071964 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mim 3.5 (Circa) Ref K052379

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mim 4.0 (Neuro Ref K060816

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mimviewer Ref K062163

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2008

    • 23 Apr 2008 Z-1827-2008 Unclassified (pre-2012) Terminated In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume. Distribution: The product was sold in the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO,…
      Full distribution text The product was sold in the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI & WV. It was also sold in Europe, Asia and Canada.
      Submission numbers: K060816, K071964

Frequently asked questions

How many devices does Mimvista Corp. have in the registry?

The registry currently lists 4 devices for Mimvista Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mimvista Corp.'s devices?

Among its 4 most recently registered devices, Mimvista Corp. has devices listed in FDA 510(k) (4 devices).

What risk classes do Mimvista Corp.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Mimvista Corp.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Mimvista Corp.?

FDA recall records list 1 recall initiated by Mimvista Corp., the most recent initiated on 23 Apr 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Mimvista Corp. in the registry?

The most recently registered devices listed for Mimvista Corp. include MIM 4.1 (SEASTAR), MIM 3.5 (CIRCA), MIM 4.0 (NEURO and MIMVIEWER.

Generated automatically from registry data and not verified by a human reviewer.