Atlas FDA

SIDOS U.

FDA 510(k) clearance K803124 · decided 1981-01-22

Clearance details

K-number
K803124
Device name
SIDOS U.
Applicant
Siemens Corp.
Decision
Substantially Equivalent
Date received
1980-12-11
Decision date
1981-01-22
Days to decision
42 days
Clearance type
Traditional
Product code
KPQ
Device class
2
Regulation number
892.5840
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (K072445)Nucletron Corp.2007-09-14
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SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (K052361)Nucletron Corporation2005-10-24
ADVANTAGE SIM MD (K052345)GE Healthcare2005-09-14
SIMULIX EVOLUTION (K033470)Nucletron Corporation2004-02-04
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339)Varian Medical Systems, Inc.2003-12-30
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (P110041/S017)Siemens Corp.2025-10-17
Atellica IM Hepatitis B surface Antigen II (HBsII) (P110041/S016)Siemens Corp.2025-10-17
ADVIA Centaur HBsAgII (HBsII) (P110041/S014)Siemens Corp.2025-06-04
ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay (P110041/S015)Siemens Corp.2025-03-04
Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con (P110041/S013)Siemens Corp.2022-03-29
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf) (P110041/S012)Siemens Corp.2021-04-27
ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica (P110041/S011)Siemens Corp.2021-03-11
ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material (P110041/S010)Siemens Corp.2020-08-25