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FDA 510(k)

THERAPAX SXT 150

K-Number: K971074 · 1997-06-13

ApplicantPantak, Inc.
Decision Date1997-06-13
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAPAX SXT 150 is the device name listed in this FDA 510(k) record. The listed applicant is Pantak, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K971074. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPAX SXT 150?

THERAPAX SXT 150 is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Pantak, Inc.. The 510(k) number is K971074.

When did THERAPAX SXT 150 receive FDA 510(k) clearance?

THERAPAX SXT 150 received FDA 510(k) clearance on 1997-06-13, under 510(k) number K971074.

Who is the listed applicant for THERAPAX SXT 150?

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

What is the FDA product code for THERAPAX SXT 150?

The FDA product code for THERAPAX SXT 150 is JAD.

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 Pantak, 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.

K973315THERAPAX DXT 300 MODEL HF-300

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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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