| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850677007167 | 4.X | PACSgear Core Server | OUG | Medical Device Data System | 1 | PACSgear Core Server | |
| 2 | 00850677007341 | 3X | LLZ | System, Image Processing, Radiological | GearView Basic | |||
| 3 | 00850677007327 | 3X | LLZ | System, Image Processing, Radiological | 2 | GearView QC | ||
| 4 | 00850677007112 | 5 | PACS Scan Software CD | LLZ | System, Image Processing, Radiological | 2 | PACS Scan CD | |
| 5 | 00850677007211 | 3.X | Mod LInk | OUG | Medical Device Data System | 1 | PACSgear Mod Link | |
| 6 | 00850677007280 | 3.X | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Web | ||
| 7 | 00850677007037 | 1 | Dicom Box Image Acquisition Unit | LMA | Digitizer, Image, Radiological | 2 | Dicom Box | |
| 8 | 00850677007006 | 5 | PACS Scan Software | LLZ | System, Image Processing, Radiological | 2 | PACS Scan | |
| 9 | 00850677007303 | 2.X | Encounter Manager | OUG | Medical Device Data System | 1 | Image Link Encounter Workflow | |
| 10 | 00850677007068 | MDR Video Cart | Cart for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Cart | |
| 11 | 00850677007020 | 1 | MDR Video Image Acquisition | LMA | Digitizer, Image, Radiological | 2 | MDR Video | |
| 12 | 00850677007297 | 3.X | OUG | Medical Device Data System | 1 | Image Link | ||
| 13 | 00850677007266 | 3.X | OUG | Medical Device Data System | 1 | EHR-Gateway | ||
| 14 | 00850677007198 | 2.X | Image Link | OUG | Medical Device Data System | 1 | PACSgear Image Link | |
| 15 | 00850677007150 | 2.2.X | PSM2.2.2 | PACS Scan Mobile, Android | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
| 16 | 00850677007143 | 3.0 | PSM3.0 | The PACS Scan Mobile client is an application for mobile devices that can used t The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. | FXN,LMD | Tape, Camera, Surgical,System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
| 17 | 00850677007235 | 2.X | EHR Gateway | OUG | Medical Device Data System | 1 | PACSgear EHR Gateway | |
| 18 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | OUG | Medical Device Data System | 1 | PACSgear Web Forms | |
| 19 | 00850677007310 | 2.X | OUG | Medical Device Data System | 1 | EHR-Gateway Print | ||
| 20 | 00850677007242 | 1.X | Media Writer Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear Media Writer Web | |
| 21 | 00850677007181 | 2.X | PACS Scan Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear PACS Scan Web | |
| 22 | 00850677007396 | 5.1.X | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
| 23 | 00850677007389 | 1.X | Image Link Plus supports imaging workflows that do not follow the radiology work Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR). | OUG | Medical Device Data System | 1 | Image Link Plus | |
| 24 | 00850677007259 | 5.X | Core Server | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
| 25 | 00850677007204 | 1.X | Image Link Encounter Workflow | OUG | Medical Device Data System | 1 | PACSgear Image Link Encounter Workflow | |
| 26 | 00850677007136 | 5 | Media Writer CD | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer CD | |
| 27 | 00850677007082 | 2 | Video Touch 4K | LMA | Digitizer, Image, Radiological | 2 | MDR Video Touch | |
| 28 | 00850677007075 | MDR Video Speech | Speech for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Speech | |
| 29 | 00850677007051 | 2 | Gearview QC Software | LLZ | System, Image Processing, Radiological | 2 | Gearview QC | |
| 30 | 00850677007273 | 4.X | Web Forms | OUG | Medical Device Data System | 1 | ModLink Web Forms | |
| 31 | 00850677007129 | 5 | Media Writer Software | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer | |
| 32 | 00850677007105 | 2 | GEAR VIEW QC CD | LLZ | System, Image Processing, Radiological | 2 | GEAR VIEW QC CD |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00841709118319 | M9D-042 / 9A682001 | M9D-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 2 | 00841709118296 | M9-042 / 9A682001 | M9-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 3 | 00841709118289 | M9-041 / 9A682001 | M9-041-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 4 | 00841709118272 | M9-040 / 9A682001 | M9-040-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 5 | 00841709118241 | M11-042 / 9A682001 | M11-042-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 6 | 00841709118234 | M11-041 / 9A682001 | M11-041-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 7 | 00841709118227 | M11-040 / 9A682001 | M11-040-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 8 | 00841492104698 | 354018 | Responder | RAULAND-BORG CORPORATION | ||
| 9 | 00841492104681 | 354017 | Responder | RAULAND-BORG CORPORATION | ||
| 10 | 00841492104667 | 354016 | Responder | RAULAND-BORG CORPORATION | ||
| 11 | 00841492104643 | 354015 | Responder | RAULAND-BORG CORPORATION | ||
| 12 | 00841492104612 | 354012 | Responder | RAULAND-BORG CORPORATION | ||
| 13 | 00841492104582 | 354011 | Responder | RAULAND-BORG CORPORATION | ||
| 14 | 00841492104575 | 354010 | Responder | RAULAND-BORG CORPORATION | ||
| 15 | 00841492104568 | 354002 | Responder | RAULAND-BORG CORPORATION | ||
| 16 | 00841492104513 | 354001WP | Responder | RAULAND-BORG CORPORATION | ||
| 17 | 00841492104490 | 354001 | Responder | RAULAND-BORG CORPORATION | ||
| 18 | 00841492104476 | 354000 | Responder | RAULAND-BORG CORPORATION | ||
| 19 | 00841492104452 | 353200 | Responder | RAULAND-BORG CORPORATION | ||
| 20 | 00841492104445 | 353101 | Responder | RAULAND-BORG CORPORATION | ||
| 21 | 00841492104438 | 353100 | Responder | RAULAND-BORG CORPORATION | ||
| 22 | 00841492104421 | 353010 | Responder | RAULAND-BORG CORPORATION | ||
| 23 | 00841492104384 | 353001 | Responder | RAULAND-BORG CORPORATION | ||
| 24 | 00841492104360 | 353000 | Responder | RAULAND-BORG CORPORATION | ||
| 25 | 00841492104353 | 352021 | Responder | RAULAND-BORG CORPORATION | ||
| 26 | 00841492104339 | 352010 | Responder | RAULAND-BORG CORPORATION | ||
| 27 | 00841492104322 | 352004 | Responder | RAULAND-BORG CORPORATION | ||
| 28 | 00841492104308 | 352000 | Responder | RAULAND-BORG CORPORATION | ||
| 29 | 00841492104285 | 351310 | Responder | RAULAND-BORG CORPORATION | ||
| 30 | 00841492104261 | 351300 | Responder | RAULAND-BORG CORPORATION | ||
| 31 | 00841492104254 | 351205 | Responder | RAULAND-BORG CORPORATION | ||
| 32 | 00841492104186 | 351004 | Responder | RAULAND-BORG CORPORATION | ||
| 33 | 00841492104179 | 351003 | Responder | RAULAND-BORG CORPORATION | ||
| 34 | 00841492104155 | 351001 | Responder | RAULAND-BORG CORPORATION | ||
| 35 | 00841492104148 | 351000 | Responder | RAULAND-BORG CORPORATION | ||
| 36 | 00841492104094 | 350300 | Responder | RAULAND-BORG CORPORATION | ||
| 37 | 00841492104087 | 350034 | Responder | RAULAND-BORG CORPORATION | ||
| 38 | 00841492103899 | 3225300 | Responder | RAULAND-BORG CORPORATION | ||
| 39 | 00841492103806 | 301103 | Responder | RAULAND-BORG CORPORATION | ||
| 40 | 00841492102564 | R5KURTA | Responder | RAULAND-BORG CORPORATION | ||
| 41 | 00841492102557 | R5KUPS1 | Responder | RAULAND-BORG CORPORATION | ||
| 42 | 00841492102533 | R5KUPB2 | Responder | RAULAND-BORG CORPORATION | ||
| 43 | 00841492102526 | R5KUCNL | Responder | RAULAND-BORG CORPORATION | ||
| 44 | 00841492102502 | R5KSSTF | Responder | RAULAND-BORG CORPORATION | ||
| 45 | 00841492102496 | R5KSMST | Responder | RAULAND-BORG CORPORATION | ||
| 46 | 00841492102489 | R5KSDTY | Responder | RAULAND-BORG CORPORATION | ||
| 47 | 00841492102472 | R5KPS1V | Responder | RAULAND-BORG CORPORATION | ||
| 48 | 00841492102465 | R5KPS1LCA | Responder | RAULAND-BORG CORPORATION | ||
| 49 | 00841492102458 | R5KPS1EA | Responder | RAULAND-BORG CORPORATION | ||
| 50 | 00841492102441 | R5KPS1A | Responder | RAULAND-BORG CORPORATION |