No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08057014730050 | 10 MeV | 900050001 | LIAC is intended for use in radiation therapy in the operating theatre on a pati LIAC is intended for use in radiation therapy in the operating theatre on a patient from whom the surgeon has just removed a neoplasia.The device may solely be used for oncological radiation therapy. The contraindications are related to use on non-oncological patients.To this end, the mobile structure with its equipment is moved to the patient at the appropriate time and placed in a position such that the applicator can be connected.At this point, the operating theatre is evacuated and the radiation command given from the console outside, after which the mobile structure is removed and surgery completed.The radiation time is normally not more than two minutes and therefore does not significantly affect the surgery time. The machine may only be used by radiation therapy or surgery staff previously trained for its use.In order to reduce the dose to the healthy tissues of the patient during the therapeutic treatment, the specific Abdominal Radiation Protection Screens must be used. The control console normally does not require sterilization but only regular cleaning.LIAC is intended to be used in a public and private health environment.LIAC is intended to be handled by trained personnel (operators)authorised by the user (authority responsible). | IYE | Accelerator, Linear, Medical | 2 | LIAC |
2 | 08057014730487 | 10 MeV | N300000-01-03 | The NOVAC 11 is an electron linear accelerator used for radiation therapy during The NOVAC 11 is an electron linear accelerator used for radiation therapy duringsurgical procedures in an operating room for the treatment of malignant and benignconditions. Known as Intraoperative Radiation Therapy (IORT), this technique allowsdelivery of high doses of radiation directly aimed at tumors or other sites while avoidingdosage to surgically mobilized normal tissues.The NOVAC 11 is a mobile and articulated machine that can be moved towards thepatient and put in the appropriate position to carry out the necessary radiotherapy. | IYE | Accelerator, Linear, Medical | 2 | NOVAC11 |
3 | 08057014730470 | Diameter 100 mm | N394100-02-05 | The absorber shields are discs used to radioprotect the patient’s organs. They s The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. | IYE | Accelerator, Linear, Medical | 2 | ABSORBER SHIELD |
4 | 08057014730463 | Diameter 90 mm | N394090-02-05 | The absorber shields are discs used to radioprotect the patient’s organs. They s The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. | IYE | Accelerator, Linear, Medical | 2 | ABSORBER SHIELD |
5 | 08057014730456 | Diameter 80 mm | N394080-02-05 | The absorber shields are discs used to radioprotect the patient’s organs. They s The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. | IYE | Accelerator, Linear, Medical | 2 | ABSORBER SHIELD |
6 | 08057014730449 | Diameter 70 mm | N394070-02-05 | The absorber shields are discs used to radioprotect the patient’s organs. They s The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. | IYE | Accelerator, Linear, Medical | 2 | ABSORBER SHIELD |
7 | 08057014730432 | Diameter 60 mm | N394060-02-05 | The absorber shields are discs used to radioprotect the patient’s organs. They s The absorber shields are discs used to radioprotect the patient’s organs. They shall beinserted below the tissue treated during the surgery. They can be inserted within the surgicalincision. | IYE | Accelerator, Linear, Medical | 2 | ABSORBER SHIELD |
8 | 08057014730425 | Diameter 50 mm | N394050-02-05 | The absorber shields are discs used to radioprotect the patient’s organs . They The absorber shields are discs used to radioprotect the patient’s organs . They shall beinserted below the tissue treated during the surgery. They can be inserted within the surgicalincision. | IYE | Accelerator, Linear, Medical | 2 | ABSORBER SHIELD |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00714646000453 | 00-0601 | 00-0601 | Multi-Treatment Base | Pelvis Belly Multi-Treatment Base | BIONIX, LLC |
2 | 00714646000446 | PBRT-6240 | PBRT-6240 | Prone Breast Bridge: Large | Prone Breast Bridge: Large | BIONIX, LLC |
3 | 00714646000422 | PBRT-6025-03 | PBRT-6025-03 | Prone Breast: Baseless Treatment System | Prone Breast System | BIONIX, LLC |
4 | 00714646000415 | HNRT-3501 | HNRT-3501 | TruGuard, Standard | TruGuard™ | BIONIX, LLC |
5 | 00714646000408 | BKRT-5038 | BKRT-5038 | SecureFoam, Large, Component B | SecureFoam™ Large | BIONIX, LLC |
6 | 00714646000392 | BKRT-5038 | BKRT-5038 | SecureFoam, Large, Component A | SecureFoam™ Large | BIONIX, LLC |
7 | 00714646000385 | BKRT-5037 | BKRT-5037 | SecureFoam. Medium, Component B | SecureFoam™ Medium | BIONIX, LLC |
8 | 00714646000378 | BKRT-5037 | BKRT-5037 | SecureFoam, Medium, Component A | SecureFoam™ Medium | BIONIX, LLC |
9 | 00714646000354 | BKRT-5036 | BKRT-5036 | SecureFoam, Small, Component B | SecureFoam™ Small | BIONIX, LLC |
10 | 00714646000347 | BKRT-5036 | BKRT-5036 | SecureFoam, Small, Component A | SecureFoam™ Small | BIONIX, LLC |
11 | 00714646000330 | PPRT-5106 | PPRT-5106 | Pelvis Belly, Large Stomach Cushion | Pelvis Belly Large Abdominal Insert | BIONIX, LLC |
12 | 00714646000323 | 5105-00-03 | 5105-00-03 | Pelvis Belly Pad Set | Pelvis Belly Plus System | BIONIX, LLC |
13 | 00714646000316 | SVRT-7450-A | SVRT-7450-A | SecureVac Cushion 100CM X 100CM, 50L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
14 | 00714646000293 | SVRT-7915 | SVRT-7915 | SecureVac Cushion 70CM X 50CM, 15L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
15 | 00714646000286 | SVRT-7820-A | SVRT-7820-A | SecureVac Cushion 70CM X 70CM, 20L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
16 | 00714646000279 | SVRT-7635 | SVRT-7635 | SecureVac Cushion 115CM X 114CM, 35L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
17 | 00714646000262 | SVRT-7630 | SVRT-7630 | SecureVac Cushion 115CM X 114CM, 25L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
18 | 00714646000255 | SVRT-7625 | SVRT-7625 | SecureVac Cushion, T-Vac | SecureVac™ Immobilization System | BIONIX, LLC |
19 | 00714646000248 | SVRT-7600 | SVRT-7600 | SecureVac Cushion, TriVac | SecureVac™ Immobilization System | BIONIX, LLC |
20 | 00714646000231 | SVRT-7535-A | SVRT-7535-A | SecureVac Cushion 100CM X 70CM, 35L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
21 | 00714646000224 | SVRT-7380 | SVRT-7380 | SecureVac Cushion 150CM X 100CM, 80L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
22 | 00714646000217 | SVRT-7134 | SVRT-7134 | SecureVac Cushion 80CM X 150CM, 70L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
23 | 00714646000200 | SVRT-7133 | SVRT-7133 | SecureVac Cushion 80CM X 150CM, 55L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
24 | 00714646000194 | SVRT-7132 | SVRT-7132 | SecureVac Cushion 80CM X 150CM, 47L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
25 | 00714646000187 | SVRT-7131 | SVRT-7131 | SecureVac Cushion 80CM X 150CM, 35L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
26 | 00714646000170 | SVRT-7130 | SVRT-7130 | SecureVac Cushion 150CM X 70CM, 55L Fill | SecureVac™ Immobilization System | BIONIX, LLC |
27 | 00714646000026 | BKRT-5040 | BKRT-5040 | SecureFoam Pouch-Pro 5/box | SecureFoam™ Pouch-Pro® | BIONIX, LLC |
28 | 00628341930420 | 1 | PH08-K | Freedom Prone Head & Neck Immobilization (MR Conditional) | Freedom | CDR SYSTEMS INC |
29 | 00628341930406 | 1 | S-Bolus | Solid Bolus | Solid Bolus | CDR SYSTEMS INC |
30 | 00628341930369 | 1 | PLUS-K | PLUS Intuition Adapter Plate (MR Conditional) | Freedom | CDR SYSTEMS INC |
31 | 00628341930352 | 1 | PLUS | PLUS Intuition Adapter Plate | Freedom | CDR SYSTEMS INC |
32 | 00628341930345 | 1 | PH08 | Freedom Prone Head & Neck Immobilization | Freedom | CDR SYSTEMS INC |
33 | 00628341930338 | 1 | SB-HP | Freedom Hand Indexer for Linac Couches | Freedom | CDR SYSTEMS INC |
34 | 00628341930321 | 1 | IFF03 | Instaform Kit | Instaform | CDR SYSTEMS INC |
35 | 00628341930307 | 1 | BB09-D | Koilia Mikros Belly Board | Koilia Mikros | CDR SYSTEMS INC |
36 | 00628341930291 | 1 | PB17-K | Procline (MR Conditional) | Prone Breast | CDR SYSTEMS INC |
37 | 00628341930284 | 1 | PB17 | Procline | Prone Breast | CDR SYSTEMS INC |
38 | 00628341930277 | 1 | PB06 | Prone Breast Positioning | Prone Breast | CDR SYSTEMS INC |
39 | 00628341930260 | 1 | SBS14-K | SaBella Flex Dual Axis Precision Positioning Overlay Only (MR Conditional) | Sabella Flex | CDR SYSTEMS INC |
40 | 00628341930253 | 1 | SBS14 | SaBella Flex Dual Axis Precision Positioning Overlay Only | Sabella Flex | CDR SYSTEMS INC |
41 | 00628341930246 | 1 | TP | Table Pad | Table Pads | CDR SYSTEMS INC |
42 | 00628341930239 | 1 | THS03 | Cranial Head Support | Positioning Aids | CDR SYSTEMS INC |
43 | 00628341930222 | 1 | Thermoplastic Immobilization Materials | Thermoplastic | CDR SYSTEMS INC | |
44 | 00628341930215 | 1 | COMP-KIT | Compression Belt | Freedom | CDR SYSTEMS INC |
45 | 00628341930208 | 1 | BM02-T | Roll Adapter | Freedom | CDR SYSTEMS INC |
46 | 00628341930192 | 1 | SB02-ST | Freedom 6 Couch Extension, S-Type | Freedom | CDR SYSTEMS INC |
47 | 00628341930185 | 1 | SB02-S1 | Freedom 6 Couch Extension Cranial | Freedom | CDR SYSTEMS INC |
48 | 00628341930178 | 1 | SB02 | Freedom 6 Couch Extension Head & Neck | Freedom | CDR SYSTEMS INC |
49 | 00628341930161 | 1 | VB | Vacuum Lock Cushion | Vacuum Lock | CDR SYSTEMS INC |
50 | 00628341930154 | 1 | IB06-K | Index Bar (MR Conditional) | Index Bar | CDR SYSTEMS INC |