Gamma Medica-Ideas Incorporated FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Gamma Medica-Ideas Incorporated has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gamma Medica-Ideas Incorporated" is on file.

What these totals cover: FDA records filed under the name "Gamma Medica-Ideas Incorporated" and its spelling variant "Gamma Medica-Ideas".

Latest inspection
Sep 10, 2010 · VAI
Latest 510(k)
Sep 23, 2011

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Sep 10, 2010.

DateSiteProductClassificationFEI
Sep 10, 2010Northridge, CADevicesVoluntary Action Indicated (VAI)3003241932
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003241932Northridge, CA1Sep 10, 2010

Recent 510(k) clearances

2 510(k) clearances from Sep 15, 2011 to Sep 23, 2011.

K-NumberDeviceDate
K111791LUMAGEM MOLECULAR BREAST IMAGING SYSTEMSep 23, 2011
K111731MOLECULAR BREAST IMAGING SOFTWARESep 15, 2011

Gamma Medica-Ideas Incorporated and the FDA: common questions

Has Gamma Medica-Ideas Incorporated received an FDA warning letter?

No FDA warning letter addressed to the name "Gamma Medica-Ideas Incorporated" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Gamma Medica-Ideas Incorporated received an FDA Form 483?

FDA has not published a Form 483 for "Gamma Medica-Ideas Incorporated" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Gamma Medica-Ideas Incorporated?

The most recent FDA inspection on file ended Sep 10, 2010 at Northridge, CA and was classified VAI. FDA has 1 inspection of Gamma Medica-Ideas Incorporated on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.