Atlas FDA

SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)

FDA 510(k) clearance K942116 · decided 1994-07-29

Clearance details

K-number
K942116
Device name
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
Applicant
Siemens Corp.
Decision
Substantially Equivalent
Date received
1994-05-03
Decision date
1994-07-29
Days to decision
87 days
Clearance type
Traditional
Product code
KPS
Device class
2
Regulation number
892.1200
Medical specialty
Radiology
Advisory committee
Radiology
Location
Hoffman Estates, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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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
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ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material (P110041/S010)Siemens Corp.2020-08-25