Product Code: IZD FDA class 1 21 CFR 892.1320

Probe, Uptake, Nuclear

Radiology

A nuclear uptake probe is a radiation detector used in nuclear medicine to measure the uptake of radioactive tracers in specific organs or tissues, most commonly thyroid gland iodine uptake studies for the evaluation of thyroid function. It is classified as FDA Class 1, the lowest risk designation, requiring only general controls with no premarket notification needed. The product code is IZD, regulated under 21 CFR 892.1320, within the Radiology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: IZD
Device Class: FDA class 1
Regulation Number: 892.1320
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

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GMP Exempt

✗

Implant

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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 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K133781	DECLIPSESPECT LAPAROSCOPY	Apr 11, 2014	Substantially Equivalent	Surgiceye GmbH
K123917	DECLIPSESPECT VIEWER	Jan 25, 2013	Substantially Equivalent	Surgiceye GmbH
K101887	CONFIDENT SURGERY SUITE 300, MODEL CSS300	Mar 22, 2011	Substantially Equivalent	Surgiceye GmbH
K013751	HANDHELD GAMMA FINDER (HGF)	Feb 06, 2002	Substantially Equivalent	Silicon Instruments Gmhb
K983768	MODIFICATION TO GAMMA GUIDANCE SYSTEM	Jul 02, 1999	Substantially Equivalent	Radiation Monitoring Devices, Inc.
K982442	C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)	Aug 25, 1998	Substantially Equivalent	Care Wise Medical Products Corp.
K971167	NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES	Jun 26, 1997	Substantially Equivalent	Neoprobe Corp.
K961321	GAMMA GUIDANCE SYSTEM	Feb 10, 1997	Substantially Equivalent	Radiation Monitoring Devices, Inc.
K962319	NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES	Sep 13, 1996	Substantially Equivalent	Neoprobe Corp.
K942580	NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES	Feb 09, 1995	Substantially Equivalent	Neoprobe Corp.
K932153	THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME	Sep 07, 1993	Substantially Equivalent	Biodan Medical Systems, Ltd.
K930962	CAPTUS 2000 WEL COUNTER	May 18, 1993	Substantially Equivalent	Capintec Instruments, Inc.
K924586	CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE	Dec 03, 1992	Substantially Equivalent	Capintec Instruments, Inc.
K922117	C-TRAK BIOPSY SYSTEM	Oct 14, 1992	Substantially Equivalent	Care Wise Medical Products Corp.
K915279	NEOPROBE PORTABLE RADIOSCOPE DETECTOR	Jun 10, 1992	Substantially Equivalent	Neoprobe Corp.
K921428	CAPTUS 500	May 28, 1992	Substantially Equivalent	Capintec Instruments, Inc.
K920115	MEDISCINT	Mar 30, 1992	Substantially Equivalent	Oakfield Instruments, Ltd.
K913055	THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900	Sep 06, 1991	Substantially Equivalent	Atomic Products Corp.
K902460	CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)	Aug 28, 1990	Substantially Equivalent	Oakfield Instruments, Ltd.
K896540	ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE	Apr 19, 1990	Substantially Equivalent	Nuclear Data Systems
K896588	ONCOPROBE II SYSTEM	Mar 14, 1990	Substantially Equivalent	Care Wise Medical Products Corp.
K891466	ACCUSPEC THYROID UPTAKE SYSTEM	Jun 06, 1989	Substantially Equivalent	Nuclear Data, Inc.
K884770	ONCOPROBE SYSTEM	Jan 04, 1989	Substantially Equivalent	Care Wise Medical Products Corp.
K864263	NEOPROBE PORTABLE RADIOISOTOPE DETECTOR	Dec 29, 1986	Substantially Equivalent	Neoprobe Corp.
K841440	ND62T THYROID UPTAKE SYSTEM	Jun 05, 1984	Substantially Equivalent	Nuclear Data, Inc.
K833140	THYROID UPTAKE SYSTEM	Dec 08, 1983	Substantially Equivalent	Advanced Medical Research Corp.
K810006	TOMOMATIC 64	Feb 02, 1981	Substantially Equivalent	Medimatic
K781742	INHAMATIC 33	Dec 04, 1978	Substantially Equivalent	Medimatic
K771301	DIGITAL RADIATION DETECTOR	Aug 04, 1977	Substantially Equivalent	Actus, Inc.
K760595	CARDIAC PROBE	Sep 17, 1976	Substantially Equivalent	G.D. Searle and Co.