510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Spectrum Dynamics Medical Inc.

Caesarea North Ind. Park Central, IL

Spectrum Dynamics Medical Inc. appears in FDA device records in Caesarea North Ind. Park Central, IL. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 8 510(k) clearances for Spectrum Dynamics Medical Inc. between 2016 and 2026. The busiest year on record is 2018, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Spectrum Dynamics Medical Inc., by decision year
YearClearances
20161
20182
20191
20211
20231
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)KPSSubstantially Equivalent
K253532TruSPECT Processing StationQIHSubstantially Equivalent
K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)KPSSubstantially Equivalent
K212230TruSPECT Radiological Image Processing StationLLZSubstantially Equivalent
K190457VERITON CT whole body SPECT/CT systemKPSSubstantially Equivalent
K182484VERITON CT whole body SPECT/CT systemKPSSubstantially Equivalent
K180514VERITON NMKPSSubstantially Equivalent
K161740D-SPECT Scanner, D-SPECT L ScannerKPSSubstantially Equivalent

Registered establishments

FDA registered establishments for Spectrum Dynamics Medical Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30080073103008007310Spectrum Dynamics Medical Inc.301 N. Cattlemen Rd. Suite 109, Sarasota, FL 34232 US2026
30062099333006209933Spectrum Dynamics Medical Ltd.22 Bareket St., Caesarea North Ind. Park Central 3079837 IL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain