Data / Medical devices / United States / DXTX Medical Inc.
DXTX Medical Inc.: FDA-registered device maker in Pittsburgh, PA, United States, 10 510(k) clearances
DXTX Medical Inc. is registered with the FDA (registration 3015431711) in Pittsburgh, PA, United States. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 17, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015431711
- Address
- 639 Alpha Drive, Pittsburgh, PA, United States, 15238
- Owner or operator
- DxTx Medical Inc. (10061391)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 14, 2019
- Registered through
- 2027
- Brand names listed
- 1.5 T eCoil Imaging System for Philips, 1.5 eCoil Imaging System Disposables Cervix, 1.5T Imaging Device for Siemens, 1.5T eCoil Imaging Device for GE, 1.5T eCoil Imaging System Disposables Colon, 1.5T eCoil Imaging System Disposables Prostate, 3T eCoil Imaging Device for GE, 3T eCoil Imaging System Disposables (Prostate) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Prostate Immobilizer Rectal Balloon | PCT | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2025 | K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | MOS | Substantially Equivalent | Dxtx Medical, Inc. | accessdata.fda.gov |
| February 10, 2023 | K223249 | Pro-Tx Endorectal Balloon (PROT-25) | PCT | Substantially Equivalent | Dxtx Medical, Inc. | accessdata.fda.gov |
| November 30, 2006 | K063342 | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS | MOS | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| March 15, 2006 | K060401 | MEDRAD 3.0T ECOIL IMAGING SYSTEM | MOS | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| November 17, 2005 | K053042 | MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE | MOS | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 23, 2005 | K051349 | 3.0T PROSTATE IMAGING SYSTEM | MOS | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| July 3, 1997 | K971380 | MEDRAD FLEX INTERFACE DEVICE | LNH | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 26, 1995 | K952235 | MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15 | LNH | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 26, 1995 | K952232 | MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 | LNH | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| August 10, 1990 | K901888 | PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15 | LNH | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Prostate Immobilizer Rectal Balloon
- All makers of Coil, Magnetic Resonance, Specialty
Updated July 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.