510(k) clearances

3D-RD-S

Radiopharmaceutical Imaging & Dosimetry, LLC · Radiology

K262060Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Baltimore
Advisory committee description
Radiology
Address 1
1800 Gough St.
Statement or summary
Summary
Product code
LLZ
Zip code
21231
Applicant
Radiopharmaceutical Imaging & Dosimetry, LLC
Decision date
2026-09-04
Decision code
SESE
Country code
US
Device name
3D-RD-S
Advisory committee
RA
Contact
Nadine Bonds
K number
K262060
State
MD
Date received
2026-06-18
Review advisory committee
RA
Postal code
21231
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Image Processing, Radiological
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3006611212, 3010687441, 8022257, 3011706018, 3007137598, 3023003446, 3006738448, 3006123366, 9612330, 3027158439, 1000432246, 3013283620, 3012391689, 3018133052, 3008364043, 1825014, 3015612252, 3014343888, 1054415, 9680497, 3014232555, 3019216, 3013427569, 3005517190, 3012322232, 3014146081, 3015536273, 3012761544, 3002808157, 3030179922, 3005202320, 3005916315, 3004504920, 3005930550, 3011114764, 1226773, 3038187462, 3007120336, 3000237660, 3010656400 +596 more
FEI number
3006611212, 3010687441, 3011706018, 3007137598, 3023003446, 3002807692, 3006738448, 3003714383, 3006123366, 3027158439, 3002087856, 1000432246, 3002807880, 3013283620, 3012391689, 3018133052, 3008364043, 1825014, 3015612252, 3014343888, 3014232555, 3003190524, 3019216, 3013427569, 3005517190, 3012322232, 3004571294, 3014146081, 1000139922, 3015536273, 3002626007, 3012761544, 3002808157, 3030179922, 3005202320, 3005916315, 3004504920, 3005930550, 3011114764, 3038187462 +596 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.