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Philips Nuclear Medicine, Inc.

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Philips Nuclear Medicine, Inc. makes

Philips Nuclear Medicine, Inc. makes the NM Application Suite, a software application used in nuclear medicine imaging workflows.

The NM Application Suite is a Class II medical device listed in the FDA 510(k) registry, and the company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Nm Application Suite Ref K080961

    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.

FDA recall records list 1 recall initiated by Philips Nuclear Medicine, Inc., initiated on 2007-08-21. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. 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.

  • 2007

    • 21 Aug 2007 Z-1212-2007 Unclassified (pre-2012) Terminated Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction Distribution: Worldwide Distribution; USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY,…
      Full distribution text Worldwide Distribution; USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Country of CANADA
      Submission number: K041577

Frequently asked questions

How many devices does Philips Nuclear Medicine, Inc. have in the registry?

The registry currently lists 1 device for Philips Nuclear Medicine, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Philips Nuclear Medicine, Inc.'s devices?

Among its 1 most recently registered device, Philips Nuclear Medicine, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Philips Nuclear Medicine, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Philips Nuclear Medicine, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Philips Nuclear Medicine, Inc.?

FDA recall records list 1 recall initiated by Philips Nuclear Medicine, Inc., the most recent initiated on 21 Aug 2007. 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 Philips Nuclear Medicine, Inc. in the registry?

The most recently registered devices listed for Philips Nuclear Medicine, Inc. include NM APPLICATION SUITE.

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