INTRABEAM 600
FDA 510(k) clearance K162568 · decided 2016-12-15
Clearance details
- K-number
- K162568
- Device name
- INTRABEAM 600
- Applicant
- Carl Zeiss Meditec, AG
- Decision
- Substantially Equivalent
- Date received
- 2016-09-14
- Decision date
- 2016-12-15
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Jena, DE
- Third-party review
- No
- Expedited review
- No
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| Sensus IORT System (K182641) | Sensus Healthcare, Inc. | 2019-02-21 |
| SRT-100+ (K173425) | Sensus Healthcare, Inc. | 2018-03-23 |
| Photoelectric Therapy System (K172080) | Xstrahl, Ltd. | 2017-09-29 |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (K150037) | Sensus Healthcare | 2015-10-16 |
| AXXENT CERVICAL APPLICATOR (K141343) | Icad, Inc. | 2014-09-05 |
| ESTEYA (K132092) | Nucletron B.V. | 2013-09-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003) | Carl Zeiss Meditec, AG | 2008-10-31 |
| VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001) | Carl Zeiss Meditec, AG | 2001-09-27 |
| VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002) | Carl Zeiss Meditec, AG | 2001-07-03 |
| ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER (P990048) | Carl Zeiss Meditec, AG | 2000-04-12 |
| MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079) | Carl Zeiss Meditec, AG | 1999-05-11 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078) | Carl Zeiss Meditec, AG | 1998-01-29 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077) | Carl Zeiss Meditec, AG | 1996-08-01 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075) | Carl Zeiss Meditec, AG | 1996-04-02 |