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)

X-RAY MARKER

K-Number: K882519 · 1988-08-09

ApplicantKarlin Technology, Inc.
Decision Date1988-08-09
Product CodeJAC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1988-08-09 under 510(k) number K882519. The device is classified under product code JAC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY MARKER?

X-RAY MARKER is a medical device that received FDA 510(k) clearance on 1988-08-09. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K882519.

When did X-RAY MARKER receive FDA 510(k) clearance?

X-RAY MARKER received FDA 510(k) clearance on 1988-08-09, under 510(k) number K882519.

Who is the listed applicant for X-RAY MARKER?

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

What is the FDA product code for X-RAY MARKER?

The FDA product code for X-RAY MARKER is JAC.

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 Karlin Technology, 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.

K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893201BONE PLATEK893203BONE SCREWK882525SPINAL MICROKNIFEK882073SPINAL NEEDLEK882520SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS

View all 17 devices →

Related Devices (Code: JAC)

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.

K942883DIGITAL I.D. CAMERAMiles Inc., Agfa DivisionK930752CT/MRI TOPOGRAPHIC MARKERI.Z.I. Corp.K932357FUJI EC ID CAMERAFujifilm Medical System U.S.A., Inc.K925892SOLSTICE XRAY RING MARKER PADSolstice Corp.K923533ADMARKPlanmeca USA, Inc.K926404KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4LEastman Kodak Company

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.

↑