Product Code: JWM FDA class 2 21 CFR 892.1310

System, Tomographic, Nuclear

Radiology

System, Tomographic, Nuclear is a medical imaging system that uses radioactive tracers and nuclear medicine principles to produce tomographic images of physiological processes and organ function within the body, commonly applied in oncology, cardiology, and neurology. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JWM, regulated under 21 CFR 892.1310, and falls within the Radiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: JWM
Device Class: FDA class 2
Regulation Number: 892.1310
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 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K914350	ICON COMPUTER SYSTEM	Nov 22, 1991	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K904599	D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM	Apr 23, 1991	Substantially Equivalent	DIGITAL DESIGN, INC.
K903315	ICON	Jan 09, 1991	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K901545	GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM	Jun 26, 1990	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K874473	ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM	Jul 18, 1988	Substantially Equivalent	ADAC LABORATORIES
K873075	ADAC MODEL ARC-5000, GAMMA CAMERA	Oct 30, 1987	Substantially Equivalent	ADAC LABORATORIES
K851685	DIGITAL GAMMA CAMERA GCA 601 E	Jun 14, 1985	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS
K850885	STARCAM DATA ACQUISITION & PROCESSING SYS H3300C	Jun 06, 1985	Substantially Equivalent	GENERAL ELECTRIC CO.
K851687	JUMBO DIGITAL GAMMACAMERA GCA-90B	Jun 05, 1985	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS
K851686	DIGITAL GAMMA CAMERA GCA 501S	Jun 05, 1985	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS
K841905	DOT-A, DOT-AR PXP-E, PXP-ER	Aug 09, 1984	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K832737	ECT PROCESSOR	Sep 29, 1983	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K812966	400T ECT SOFTWARE	Nov 24, 1981	Substantially Equivalent	GENERAL ELECTRIC CO.
K810873	STAR	Apr 23, 1981	Substantially Equivalent	INTL. GENERAL ELECTRIC CO.
K801917	STAR	Sep 16, 1980	Substantially Equivalent	GENERAL ELECTRIC CO.
K780369	MODUMED MUGE	Mar 14, 1978	Substantially Equivalent	MEDTRONIC VASCULAR
K780368	MODUMED MUGX	Mar 14, 1978	Substantially Equivalent	MEDTRONIC VASCULAR