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

South San Fransisco, CA, US

Imatron, Inc. appears in FDA device records in South San Fransisco, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Imatron, Inc. between 1983 and 2000. The busiest year on record is 1997, with 2. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for Imatron, Inc., by decision year
YearClearances
19831
19841
19861
19871
19881
19911
19972
19991
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K001550EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTRLLZSubstantially Equivalent
K000359EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTROJAKSubstantially Equivalent
K992740EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMSJAKSubstantially Equivalent
K972903IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONSJAKSubstantially Equivalent
K972879ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTIONJAKSubstantially Equivalent
K913352C-150 ULTRAFAST CT SCANNERJAKSubstantially Equivalent
K874934UNIVERSAL EXAMINATION TABLEKXJSubstantially Equivalent
K872615IMATRON C-100 ULTRAFAST CT SCANNERJAKSubstantially Equivalent
K864046C-IOO MOBILE CINE CT UNITJAKSubstantially Equivalent
K840131COMPUTED TOMOGRAPHY CALIBRATION PHANTIXGSubstantially Equivalent
K828669COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100Substantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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