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Riverain Medical Group

Also registered as Riverain Medical Group, Llc

Country not established

Devices
4
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Riverain Medical Group makes

Riverain Medical Group manufactures the SOFTVIEW Model 2.01, a diagnostic imaging device, and the RAPIDSCREEN RS-2000D, a rapid diagnostic screening system for medical applications.

These products are regulated as Class II devices in the US, with the SOFTVIEW Model 2.01 authorised via FDA 510(k) clearance and the RAPIDSCREEN RS-2000D through FDA PMA approval. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Softview, Model 2.01 Ref K092363

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

  • Deltaview Model 2.1 Ref K111776

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

  • Firstview Ref K071492

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

  • Rapidscreen Rs-2000D Ref P000041

    Active Regimes: PMA Registry: PMA Class:II

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Riverain Medical Group, initiated on 2006-05-04. By recorded status: 2 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2006

    • 4 May 2006 Z-1173-06 Unclassified (pre-2012) Terminated The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity. Distribution: Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN,…
      Full distribution text Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN, OK, WI, OH, AZ, IA, and PA.
      Submission number: P000041/S1
    • 4 May 2006 Z-1174-06 Unclassified (pre-2012) Terminated The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity. Distribution: Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN,…
      Full distribution text Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN, OK, WI, OH, AZ, IA, and PA.
      Submission number: P000041/S2

Frequently asked questions

How many devices does Riverain Medical Group have in the registry?

The registry currently lists 4 devices for Riverain Medical Group. Devices recorded under merged duplicate company entries are counted once.

Which registries list Riverain Medical Group's devices?

Among its 4 most recently registered devices, Riverain Medical Group has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Riverain Medical Group's devices fall under?

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

Are there FDA recall records for Riverain Medical Group?

FDA recall records list 2 recalls initiated by Riverain Medical Group, the most recent initiated on 4 May 2006. 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 Riverain Medical Group in the registry?

The most recently registered devices listed for Riverain Medical Group include SOFTVIEW, MODEL 2.01, DELTAVIEW MODEL 2.1, FIRSTVIEW and RAPIDSCREEN RS-2000D.

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