Product Code: KPT FDA class 2 21 CFR 892.1360

Calibrator, Dose, Radionuclide

Radiology

This device is a radionuclide dose calibrator used in nuclear medicine to measure the radioactivity of radiopharmaceuticals prior to patient administration, ensuring accurate dosing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPT, regulated under 21 CFR 892.1360 within the Radiology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KPT
Device Class: FDA class 2
Regulation Number: 892.1360
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192199	CRC PC Smart Chamber K1	Sep 12, 2019	Substantially Equivalent	Capintec, Inc.
K162394	CRC-77tHR	Mar 08, 2017	Substantially Equivalent	Capintec, Inc.
K142325	Veenstra Instruments VDC-506 Dose Calibrator	Sep 18, 2014	Substantially Equivalent	Comecer Netherlands B.V.
K141413	CRC PC WITH SMART CHAMBER	Jun 27, 2014	Substantially Equivalent	Capintec, Inc.
K101452	CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW	Aug 09, 2010	Substantially Equivalent	Capintec, Inc.
K090296	ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336	Feb 19, 2009	Substantially Equivalent	Biodex Medical Systems, Inc.
K071396	CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS	Jun 28, 2007	Substantially Equivalent	Capintec, Inc.
K042746	PET-DOSE	Nov 22, 2004	Substantially Equivalent	Comecer S.R.L.
K030066	CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165	Aug 29, 2003	Substantially Equivalent	Nuclear Associates
K011493	MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY	Oct 01, 2002	Substantially Equivalent	Mentor Corp.
K020150	CRC-15BT	Aug 02, 2002	Substantially Equivalent	Capintec, Inc.
K013689	RE-ENTRANT CHAMBER	Jul 02, 2002	Substantially Equivalent	Sun Nuclear Corp.
K013548	STANDARD IMAGING IVB 1000 WELL CHAMBER	Nov 09, 2001	Substantially Equivalent	Standard Imaging, Inc.
K010417	CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304	Apr 26, 2001	Substantially Equivalent	Nuclear Assoc., Div. Inovision LP
K002833	MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER	Sep 28, 2000	Substantially Equivalent	Standard Imaging, Inc.
K943072	BETA C COUNTER	Sep 29, 1994	Substantially Equivalent	Capintec Instruments, Inc.
K935539	CAPINTEC CRC 35R	Feb 18, 1994	Substantially Equivalent	Capintec Instruments, Inc.
K931657	NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.	Jul 27, 1993	Substantially Equivalent	Victoreen, Inc.
K905796	DOSE CALIBRATOR	Mar 18, 1991	Substantially Equivalent	Capintec Instruments, Inc.
K884312	ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270	Feb 16, 1989	Substantially Equivalent	Atomic Products Corp.
K880272	CAL/RAD UPGRADE MODEL 1030	Feb 29, 1988	Substantially Equivalent	Sun Nuclear Corp.
K850838	CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW	Sep 26, 1985	Substantially Equivalent	Clinicomp, Inc.
K850815	RADIOISOTOPE CALIBRATOR MODEL 34-062	Aug 21, 1985	Substantially Equivalent	Victoreen, Inc.
K842540	CLINICOMP R.C.I.	Aug 08, 1984	Substantially Equivalent	Clinicomp, Inc.
K842570	LUDLUM 88 DOSE CALIBRATOR	Aug 07, 1984	Substantially Equivalent	Ludlum Measurements, Inc.
K841787	RADCAL MODEL 4050 RADIONUCLIDE CALIB	Jul 16, 1984	Substantially Equivalent	Radcal Corp.
K841786	RADCAL MODEL 4051 RADIONUCLIDE CALIBRA	Jul 16, 1984	Substantially Equivalent	Radcal Corp.
K841785	RADCAL MODEL 4046 RADIONUCLIDE CALIBR	Jul 16, 1984	Substantially Equivalent	Radcal Corp.
K813379	RADIONUCLIDE DOSE CALIBRATOR	Jan 22, 1982	Substantially Equivalent	Medi Nuclear Corp., Inc.
K813065	B.D.A.S.	Dec 08, 1981	Substantially Equivalent	General Electric Co.
K811320	CAL-3 CALIBRATED RADIOACTIVITY ASSAYER	Jun 02, 1981	Substantially Equivalent	Dosimeter Corp.
K770515	DISPENSER, TECHNETIUM, CLINTICHEM	Apr 05, 1977	Substantially Equivalent	Union Carbide Corp.