Atlas FDA

KPT

32 FDA 510(k) clearances · Product code

76 daysmedian time to decision
209 days90th percentile
32clearances measured

FDA profile

Official device name
Calibrator, Dose, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1360
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CRC PC Smart Chamber K1 (K192199)Capintec, Inc.2019-09-12
CRC-77tHR (K162394)Capintec, Inc.2017-03-08
Veenstra Instruments VDC-506 Dose Calibrator (K142325)Comecer Netherlands B.V.2014-09-18
CRC PC WITH SMART CHAMBER (K141413)Capintec, Inc.2014-06-27
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW (K101452)Capintec, Inc.2010-08-09
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 (K090296)Biodex Medical Systems, Inc.2009-02-19
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (K071396)Capintec, Inc.2007-06-28
PET-DOSE (K042746)Comecer S.R.L.2004-11-22
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 (K030066)Nuclear Associates2003-08-29
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY (K011493)Mentor Corp.2002-10-01
CRC-15BT (K020150)Capintec, Inc.2002-08-02
RE-ENTRANT CHAMBER (K013689)Sun Nuclear Corp.2002-07-02
STANDARD IMAGING IVB 1000 WELL CHAMBER (K013548)Standard Imaging, Inc.2001-11-09
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 (K010417)Nuclear Assoc., Div. Inovision LP2001-04-26
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (K002833)Standard Imaging, Inc.2000-09-28
BETA C COUNTER (K943072)Capintec Instruments, Inc.1994-09-29
CAPINTEC CRC 35R (K935539)Capintec Instruments, Inc.1994-02-18
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. (K931657)Victoreen, Inc.1993-07-27
DOSE CALIBRATOR (K905796)Capintec Instruments, Inc.1991-03-18
ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 (K884312)Atomic Products Corp.1989-02-16
CAL/RAD UPGRADE MODEL 1030 (K880272)Sun Nuclear Corp.1988-02-29
CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW (K850838)Clinicomp, Inc.1985-09-26
RADIOISOTOPE CALIBRATOR MODEL 34-062 (K850815)Victoreen, Inc.1985-08-21
CLINICOMP R.C.I. (K842540)Clinicomp, Inc.1984-08-08
LUDLUM 88 DOSE CALIBRATOR (K842570)Ludlum Measurements, Inc.1984-08-07
RADCAL MODEL 4046 RADIONUCLIDE CALIBR (K841785)Radcal Corp.1984-07-16
RADCAL MODEL 4051 RADIONUCLIDE CALIBRA (K841786)Radcal Corp.1984-07-16
RADCAL MODEL 4050 RADIONUCLIDE CALIB (K841787)Radcal Corp.1984-07-16
RADIONUCLIDE DOSE CALIBRATOR (K813379)Medi Nuclear Corp., Inc.1982-01-22
B.D.A.S. (K813065)General Electric Co.1981-12-08
CAL-3 CALIBRATED RADIOACTIVITY ASSAYER (K811320)Dosimeter Corp.1981-06-02
DISPENSER, TECHNETIUM, CLINTICHEM (K770515)Union Carbide Corp.1977-04-05

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Every clearance here is in the API, with alerts when new ones post.