Calibrator, Dose, Radionuclide
Radiology · 21 CFR 892.1360
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Capintec IncTerminatedNov 9, 2011
Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02
Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
Z-0177-2012 · View FDA record ↗ - Capintec IncTerminatedOct 28, 2010
Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capi
The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.
Z-0167-2011 · View FDA record ↗ - Biodex Medical Systems, Inc.TerminatedUnknown
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Z-2580-2021 · View FDA record ↗ - Biodex Medical Systems, Inc.TerminatedUnknown
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Z-2581-2021 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
32 clearances for this product code
- Capintec, Inc.Sep 12, 2019
K192199 · CRC PC Smart Chamber K1
- Capintec, Inc.Mar 8, 2017
K162394 · CRC-77tHR
- Comecer Netherlands B.V.Sep 18, 2014
K142325 · Veenstra Instruments VDC-506 Dose Calibrator
- Capintec, Inc.Jun 27, 2014
K141413 · CRC PC WITH SMART CHAMBER
- Capintec, Inc.Aug 9, 2010
K101452 · CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
- Biodex Medical Systems, Inc.Feb 19, 2009
K090296 · ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
- Capintec, Inc.Jun 28, 2007
K071396 · CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
- Comecer S.R.L.Nov 22, 2004
K042746 · PET-DOSE