Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADAC MODEL ARC-5000, GAMMA CAMERA

K-Number: K873075 · 1987-10-30

ApplicantAdac Laboratories
Decision Date1987-10-30
Product CodeJWM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADAC MODEL ARC-5000, GAMMA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1987-10-30 under 510(k) number K873075. The device is classified under product code JWM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAC MODEL ARC-5000, GAMMA CAMERA?

ADAC MODEL ARC-5000, GAMMA CAMERA is a medical device that received FDA 510(k) clearance on 1987-10-30. The listed applicant is Adac Laboratories. The 510(k) number is K873075.

When did ADAC MODEL ARC-5000, GAMMA CAMERA receive FDA 510(k) clearance?

ADAC MODEL ARC-5000, GAMMA CAMERA received FDA 510(k) clearance on 1987-10-30, under 510(k) number K873075.

Who is the listed applicant for ADAC MODEL ARC-5000, GAMMA CAMERA?

The FDA 510(k) record lists Adac Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAC MODEL ARC-5000, GAMMA CAMERA?

The FDA product code for ADAC MODEL ARC-5000, GAMMA CAMERA is JWM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Adac Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062298APOLLO GAMMA CAMERA SYSTEMK061029JETSTREAM WORKSPACEK060020AUTOQUANT PLUSK051351PRECEDENCE SPECT/CT IMAGING SYSTEMK042880JETSTREAM WORKSPACEK042903AUTOSPECS

View all 88 devices →

Related Devices (Code: JWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc.K904599D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMDigital Design, Inc.K903315ICONSiemens Gammasonics, Inc.K901545GCA-9300 NUCLEAR TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.CK874473ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMAdac LaboratoriesK851685DIGITAL GAMMA CAMERA GCA 601 EToshiba Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑