Atlas FDA

SIRCAM 106

FDA 510(k) clearance K792394 · decided 1979-12-20

Clearance details

K-number
K792394
Device name
SIRCAM 106
Applicant
Siemens Corp.
Decision
Substantially Equivalent
Date received
1979-11-26
Decision date
1979-12-20
Days to decision
24 days
Clearance type
Traditional
Product code
IZJ
Device class
2
Regulation number
892.1620
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CCD CAMERA, MODEL PKP-06000-000 (K024085)Perkins Electronics Co.2003-03-11
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR (K972130)Fairmontmedical1997-10-09
DSP OPTION (K945580)Philips Medical Systems (Cleveland), Inc.1995-01-30
PHILIPS DSI SYSTEM RELEASE 3.2 (K920793)Philips Medical Systems, Inc.1992-07-17
CINE CAMERA CONTROL MODEL PK2037 (K896615)Perkins Mfg. Co.1990-01-04
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (K881688)Adac Laboratories1988-05-18
CANON X-RAY 35MM CINE CAMERA CSI-35 (K853983)Canon USA, Inc.1985-10-16
VIDICAM 200 (K812613)Diversified P.A.1981-12-08
SIRCAM 103 (K810191)Siemens Corp.1981-02-26
105MM ROLL FILM FLUOROGR. CAMERA, #105 (K810072)Scientex Corp.1981-02-12
105MM SPOT FILM CAMERA (K802132)Instrumentation Camera, Inc.1980-10-23

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