Product code IWE
- Device name
- Monitor, Patient Position, Light-Beam
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.5780
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152303 | CT Sim Laser System | Gammex, Inc. | 2015-09-11 |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Hogan & Hartson | 1997-11-20 |
| K955236 | GREEN TEC-2100 | Medtec, Inc. | 1996-05-24 |
| K954414 | CENTRALITE BACKPOINTER | Diacor, Inc. | 1995-10-23 |
| K950293 | TEC-2110 GREEN LASER MODEL MT-HNG | Medtec, Inc. | 1995-08-18 |
| K950112 | CENTRALITE(R)-DLL SERIES | Diacor, Inc. | 1995-08-16 |
| K951601 | MED-TEC STRING RETICLE TRAY | Medtec, Inc. | 1995-05-11 |
| K943802 | HP BACK POINTER SYSTEM | Medtec, Inc. | 1994-12-07 |
| K943381 | LASER ALIGNMENT TOOL | Philips Medical Systems North America, Inc. | 1994-08-09 |
| K941169 | TEC 2101 (MODEL MT-HPLGD) | Medtec, Inc. | 1994-07-18 |
| K935760 | TEC 2100 (MODEL MT-LPLGD) | Medtec, Inc. | 1994-01-25 |
| K934519 | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM | Medtec, Inc. | 1993-12-13 |
| K931974 | AZ 92 | A2j, Inc. | 1993-10-08 |
| K930294 | PATPOS GREEN | Cp Bio-Medical Corp. | 1993-06-04 |
| K930295 | PATPOS COMPACT | Cp Bio-Medical Corp. | 1993-05-21 |
| K930296 | PATPOS RED | Cp Bio-Medical Corp. | 1993-05-21 |
| K923619 | ACCULITE SSL | Medical Alignment Systems | 1992-11-16 |
| K904127 | A2J TELEMETER | A2j, Inc. | 1991-01-04 |
| K904753 | DIOLASE | Scanditronix, Inc. | 1990-11-09 |
| K893398 | CENTRALITE BACKPOINTER | Diacor, Inc. | 1989-08-17 |
| K880981 | A2J MZ 44 B TYPE | A2j, Inc. | 1988-04-22 |
| K872894 | A2J MZ 44 LASER LIGHT FOR POSITIONING | Prometex, Inc. | 1987-08-12 |
| K872841 | ACCULITE | Medical Alignment Systems | 1987-08-12 |
| K872489 | CENTRALITE | Diacor, Inc. | 1987-07-15 |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Nuclear Diagnostics, Inc. | 1986-07-03 |
| K801541 | WALL MOUNTED LASER POSITIONING DEVICE | Advantage Medical Systems, Inc. | 1980-08-20 |
| K800489 | LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 | Atc Medical Technology, Inc. | 1980-03-25 |
| K800223 | PATIENT POSITIONING SYSTEM 1D OR 2D | Laboratoire National D'Essais | 1980-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840348505399 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-12 |
| 00840348505382 | AADCO | AADCO MEDICAL, INC. | 2022-12-12 |
| 00840348505375 | AADCO | AADCO MEDICAL, INC. | 2022-12-12 |
| 00840348505368 | AADCO | AADCO MEDICAL, INC. | 2022-12-12 |
| 00840348505351 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-12 |
| 00840348505344 | AADCO | AADCO MEDICAL, INC. | 2022-12-12 |
| 00840348502503 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502695 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502688 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502565 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502558 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502541 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502534 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502527 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502510 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502497 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502480 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502473 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502466 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502459 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502442 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502435 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502428 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502411 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502404 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502398 | Hercules | AADCO MEDICAL, INC. | 2022-12-09 |
| 00840348502350 | Hercules | AADCO MEDICAL, INC. | 2022-12-08 |
| 00840348502381 | MRI-Safe | AADCO MEDICAL, INC. | 2022-12-08 |
| 00840348502374 | Hercules | AADCO MEDICAL, INC. | 2022-12-08 |
| 00840348502367 | Hercules | AADCO MEDICAL, INC. | 2022-12-08 |