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FDA 510(k)

PORTA RAY MODEL 325

K-Number: K864339 · 1986-12-15

ApplicantPorta Ray, Inc.
Decision Date1986-12-15
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTA RAY MODEL 325 is the device name listed in this FDA 510(k) record. The listed applicant is Porta Ray, Inc.. It received FDA 510(k) clearance on 1986-12-15 under 510(k) number K864339. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA RAY MODEL 325?

PORTA RAY MODEL 325 is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Porta Ray, Inc.. The 510(k) number is K864339.

When did PORTA RAY MODEL 325 receive FDA 510(k) clearance?

PORTA RAY MODEL 325 received FDA 510(k) clearance on 1986-12-15, under 510(k) number K864339.

Who is the listed applicant for PORTA RAY MODEL 325?

The FDA 510(k) record lists Porta Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA RAY MODEL 325?

The FDA product code for PORTA RAY MODEL 325 is IZO.

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 Porta Ray, Inc. 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.

K811082BETA I & BETA IIK810276ALPHA I AND ALPHA IIK792665PIXIE

Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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.

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