510(k) K013548
- Device
- STANDARD IMAGING IVB 1000 WELL CHAMBER
- Applicant
- STANDARD IMAGING, INC.
- 510(k) number
- K013548
- Product code
- KPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-09
- Date received
- 2001-10-24
- Regulation
- 892.1360
- Classification name
- Calibrator, Dose, Radionuclide
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND RIDDLE
- Address
- 7601 Murphy Dr. Middleton WI US 53562 53562
FDA Registration Numbers#
- 3009694288
- 2518443
Source Documents#
Other 510(k) Records For Product Code KPT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | Capintec, Inc. | 2019-09-12 |
| K162394 | CRC-77tHR | Capintec, Inc. | 2017-03-08 |
| K142325 | Veenstra Instruments VDC-506 Dose Calibrator | Comecer Netherlands B.V. | 2014-09-18 |
| K141413 | CRC PC WITH SMART CHAMBER | Capintec, Inc. | 2014-06-27 |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | Capintec, Inc. | 2010-08-09 |
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | Biodex Medical Systems, Inc. | 2009-02-19 |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | 2007-06-28 |
| K042746 | PET-DOSE | Comecer S.R.L. | 2004-11-22 |
| K030066 | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | Nuclear Associates | 2003-08-29 |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Mentor Corp. | 2002-10-01 |
| K020150 | CRC-15BT | Capintec, Inc. | 2002-08-02 |
| K013689 | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | 2002-07-02 |
| K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | 2001-04-26 |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | Standard Imaging, Inc. | 2000-09-28 |
| K943072 | BETA C COUNTER | Capintec Instruments, Inc. | 1994-09-29 |
Legacy Summary#
summary
FDA Review#
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