Instrument, Quality-Assurance, Radiologic
45 catalogue numbers from DIAMENTOR ED remote display, listed by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, under Instrument, Quality-Assurance, Radiologic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
Record
| Listed by | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH |
|---|---|
| FDA product code | LHO |
| Device type | Instrument, Quality-Assurance, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1940 |
| Premarket notification | Exempt |
| Record published | 2017-04-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DIAMENTOR ED remote display | In distribution | |
| SFD mammo chamber 6 cm³ | In distribution | |
| PEAKFINDER | In distribution | |
| DiaControl Expert software | In distribution | |
| MP1Control software | In distribution | |
| CT ion chamber, 300 mm long | In distribution | |
| Track-it software | In distribution | |
| DIAMENTOR SD secondary display | In distribution | |
| IsoCheck software | In distribution | |
| CT ion chamber, 300 mm long | In distribution | |
| CT ion chamber 3.14 cm³ | In distribution | |
| DiaCom software | In distribution | |
| epidSoft software | In distribution | |
| SFD diagnostic chamber, 75 cm³ | In distribution | |
| CT ion chamber, 300 mm long | In distribution | |
| DiaCom software | In distribution | |
| SFD diagnostic chamber, 75 cm³ | In distribution | |
| WedgeAngle Software | In distribution | |
| MultiSoft software | In distribution | |
| SFD MAM chamber, 6 cm³ | In distribution | |
| BeamAdjust | In distribution | |
| DIAMENTOR SD secondary display, backlit | In distribution | |
| IsoCheck epid software | In distribution | |
| SFD diagnostic chamber, 75 cm³ | In distribution | |
| SFD diagnostic chamber, 75 cm³ | In distribution | |
| CT ion chamber 3.14 cm³ | In distribution | |
| CT ion chamber 3.14 cm³, 100 mm long | In distribution | |
| DIAMENTOR ED remote display | In distribution | |
| MAM detector | In distribution | |
| CT ion chamber 3.14 cm³ | In distribution | |
| SFD mammo chamber 6 cm³ | In distribution | |
| SERVO CONTROL UNIT | In distribution | |
| SFD mammo chamber 6 cm³ | In distribution | |
| SFD diagnostic chamber, 75 cm³ | In distribution | |
| DiaCanSet software | In distribution | |
| FilmScan software | In distribution | |
| R/F/D detector | In distribution | |
| TanSoft software | In distribution | |
| CT ion chamber 9.3 cm³, 300 mm long | In distribution | |
| PeakScan software | In distribution | |
| MP3Control software | In distribution | |
| CT ion chamber 3.14 cm³ | In distribution | |
| SFD mammo chamber 6 cm³ | In distribution | |
| CONNY II | In distribution | |
| MultiCal software | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Quasar | Modus Medical Devices, Inc. | 93 |
| Easy Cube | L A P Gmbh Laser Applikationen | 91 |
| KermaX-plus | IBA Dosimetry GmbH | 74 |
| Easy Slab | L A P Gmbh Laser Applikationen | 68 |
| Diamentor | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 42 |
| Octavius | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 16 |
| RW3 slab phantom | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 13 |
| Vista | Modus Medical Devices, Inc. | 13 |
| Ruby | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 10 |
| MP1 Manual Water Phantom | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 10 |
| Couchfix | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 7 |
| VolparaDoseRT | Lunit Inc. | 4 |
Showing 12 of 163. All products under Instrument, Quality-Assurance, Radiologic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| PTW Freiburg | UDI-DI | 2023-06-07 | Class II | Under Investigation by firm | Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will | 42 US |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.