510(k) K973162
- Device
- DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
- Applicant
- HOGAN & HARTSON
- 510(k) number
- K973162
- Product code
- IWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-20
- Date received
- 1997-08-22
- Regulation
- 892.5780
- Classification name
- Monitor, Patient Position, Light-beam
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 1038814
- 3003768277
- 1225473
- 2436865
- 3027645317
- 3015218501
- 3017956012
- 3000126629
- 3007615597
- 3003768251
- 9681134
- 3043088937
- 1720753
- 1055485
- 3043138885
- 2029275
- 3031218453
- 9681477
- 3006621300
- 1219183
Source Documents#
Other 510(k) Records For Product Code IWE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152303 | CT Sim Laser System | Gammex, Inc. | 2015-09-11 |
| 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 |
Legacy Summary#
summary
FDA Review#
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