GE LOGIQ 7 ULTRASOUND BT05
Device Facts
| Record ID | K052441 |
|---|---|
| Device Name | GE LOGIQ 7 ULTRASOUND BT05 |
| Applicant | General Electric Co. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 21, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The device is intended for use by a qualified physician for ultrasound evaluation (breast, thyroid); Neonatal Cephalic; Adult Cephalic; OB Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Musculoskeletal Conventional and Superficial, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Device Story
GE LOGIQ 7 BT05 is a general-purpose diagnostic ultrasound system; provides digital acquisition, processing, and display of ultrasound images. System includes CRT or LCD display, LCD touch panel, and computer keyboard. Operates via pulsed echo and Doppler imaging modes. Used by qualified physicians in clinical settings for diagnostic evaluation of various anatomical regions. Input consists of ultrasound signals from transducers; system transforms these into visual images and measurements for clinical assessment. Output assists clinicians in diagnosis and monitoring of patient conditions. Benefits include non-invasive visualization of internal structures and blood flow.
Clinical Evidence
No clinical data required. Device safety and effectiveness supported by non-clinical bench testing, including acoustic output measurements, biocompatibility, and electrical/mechanical safety testing in accordance with applicable standards.
Technological Characteristics
Diagnostic ultrasound system utilizing pulsed echo and Doppler imaging. Includes transducers (4C, 4D3C-L, 4D10L, i739/t739). Features digital acquisition, processing, and display (CRT/LCD). Supports B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging, and Coded Pulse modes. Real-time 3D/4D acquisition supported with specific probes. Conforms to 21 CFR 892.1550, 892.1560, and 892.1570. Quality system compliant with ISO 13485.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring evaluation of breast, thyroid, neonatal/adult cephalic, fetal/obstetric, abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transesophageal, and intraoperative (abdominal, thoracic, vascular, neurosurgical) structures.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- GE LOGIQ 7 Diagnostic Ultrasound System (K010329, K032182, K04181)
Related Devices
- K032182 — GE LOGIQ 7, MODEL 2354858 · General Electric Co. · Jul 25, 2003
- K041813 — GE LOGIQ 7 ULTRASOUND BT04 · Ge Medical Systems Ultrasound and Primary Care Dia · Jul 23, 2004
- K030934 — GE LOGIQ 9 MODEL 2375600 · Ge Medical Systems, Inc. · Apr 17, 2003
- K020263 — LOGIQ 3 · General Electric Co. · Feb 6, 2002
- K032477 — GE LOGIQ BOOK · General Electric Co. · Oct 22, 2003
Submission Summary (Full Text)
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K052441
SEP 2 1 2005
Special 510(k) Premarket Notification GE LOGIQ 7 Ultrasound BT05 September 2, 2005
# Attachment B:
Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The logo is black and white.
GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
#### Section a):
| 1. | Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC<br>PO Box 414<br>Milwaukee, WI 53201 |
|----|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Allen Schuh,<br>Manager, Safety and Regulatory Engineering<br>Telephone: 414-647-4385; Fax: 414-647-4090 |
| | Date Prepared: | September 2, 2005 |
| 2. | Device Name: | GE LOGIQ 7 Diagnostic Ultrasound System, BT05<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
| 3. | Marketed Device: | GE LOGIQ 7 Diagnostic Ultrasound System K010329, K032182, K04181 |
3 3. Marketed Device: A device currently in commercial distribution.
4. Device Description: The GE LOGIQ 7 is a full featured general purpose diagnostic uitrasond bystem. 4. Device Describitori. The OC EOON Ploade, 100 cm deep and 140-160 cm (adjustable) high The user interface includes a that provides digital acquisition, processing and display capability. that provides "digital" acquisition, "processing" and a color video CRT or LCD image display & LCD touch panel. Computer Reyboard, Specialized official and a color rease acquisition, additional measurements and productivity enhancement.
5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation ാ. Indications for USC. The deville Io Incent (breast, thyroid); Neonatal Cephalic; Adult Cephalic; OF Fetal, Addonimal, Fediatio, Onliar Organ (Irondo, Releatal Conventional and Superficial, Gardias (addit and poditation), Polipiter researchageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
6. Comparison with Predicate Device: The GE LOGIQ 7 BT05 is of a comparable type and substantially o. Our partson with Fredicall Boths. It has the same technological characteristics, key safety and equivalent to the banon. De Lesign, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.
#### Section b):
1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, creaning and 1. Norrainidal rosts. The down has been , electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
2. Clinical Tests: None required.
3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA 5. Goricusion: michod doos and other key to see in and development process of the guldelines, and octorned model and ISO 13485 quality systems. The device manforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrassund has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ 7 BT04 Sale and onlootive performantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, which are often interpreted as an abstract representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### SEP 2 1 2005
Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering GE Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue WEST MILWAUKEE WI 53219
Re: K052441
Trade Name: GE LOGIQ 7 Ultrasound System Trade Name: CE ES STORE FR 892.1550, 892.1560, and 892.1570 Regulation Name: Ultrasonic pulsed doppler imaging system Ultrasonic pulsed echo imaging system Diagnostic ultrasonic transducer Regulatory Class: II
Product Code: IYN, IYO, and ITX
Dated: September 2, 2005
Received: September 6, 2005
Dear Mr. Schuh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) promative is substantially equivalent (for the referenced above and we nave determined the arrily marketed predicate devices marketed in indications for use stated in the encreations of the enactment date of the Medical Device interslate commerce proc to May 20, 1970, the entired in accordance with the provisions of the Amendments, or to devices mat liave been receive, market the device, subject to Federal Food, Drug, and Cosmette Act. The general controls provisions of the Act include the general controls provisions of the Act. "The general of the super of the manufacturing practice, labeling, requirements against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for I his determination of substantar equivalenee uppressions in your premarket notification:
Transducer Model Number
4C 4D3C-L 4D10L i739 or t739
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### Page 2 -- Mr. Schuh
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into entires major regulations affecting your device (roddition, FDA It may be subject to such additional controls: "Zhoting 21, Parts 800 to 898. In addition, FDA Can be found in the Code of I eachar roganized in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuance of a sucsainnial equirements of the Act
that FDA has made a determination that your device complies with other water that FDA has made a decidimation that Jour secred by other Federal agencies. You must or any Federal Statutes and regulations administers by of not limited to: registration and listing (21 comply with an the Act 3 requirements, news and acturing practice requirements as set CFK Fart 807), ademig (21 OFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I his determination of Substance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested Information, meruding acoused of the Center's September 30, 1997 "Information for Manufacturers" in Appendix CT, (enclosed) of the Center 3 Beptems and Transducers'. If the special Seeking Marketing Clearance of Diagnosto Of Diagram - Structic output greater than approved report is mobiliplete of commis unaceptation units which (as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and The special report of & ADD-TO-FILE" and should be submitted in duplicate to:
| Food and Drug Administration |
|--------------------------------------------|
| Center for Devices and Radiological Health |
| Document Mail Center (HFZ-401) |
| 9200 Corporate Boulevard |
| Rockville, Maryland 20850 |
This letter will allow you to begin marketing your device as described in your premarket I fills letter will anow you to oegin nameling your device to a legally marketed noutication. The I Driving of basian for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you ucsile specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Compilance at (21 notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainter nobilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
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Page 3 – Mr. Schuh . . . .
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İf you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Ingram
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
# Enclosure(s)
Comments of the comments of
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### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ 7 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | P | P | P | P | P | P | P | | |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intracperative includes abdominal, thoracic (cardiac), and vascular (PV).
["] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[ ] Sombinou modes real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
E-2
{5}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 7 with 4C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical<br>Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | | N | N | N | N | N | N | | |
| Abdominal[1] | N | N | N | | N | N | N | N | N | N | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | N | N | N | | N | N | N | N | N | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | N | N | N | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | N | N | N | | N | N | N | N | N | N | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[4] Other use includes Urology;
["] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leyson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number K052441
Prescription Use (Per 21 CFR 801.109)
**E-3**
{6}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 7 with 4D3C-L Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical<br>Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | | N | | N | N | N | N | | |
| Abdominal[1] | N | N | N | | N | | N | N | N | N | | |
| Pediatric | N | N | N | | N | | N | N | N | N | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | N | N | N | | N | | N | N | N | N | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| | | | | | | | | | | | | |
Eaparooople
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[4] Other use includes Urology;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
I I Combined model are bring in the elevational plane providing real-time 3D acquisition.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel R. Larson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
Prescription Use (Per 21 CFR 801.109)
----------------------------------------------
E-4
{7}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 7 with 4D10L Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | | | | | Mode of Operation | | | | | |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
["] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ] Ochained than anay motion in the elevational plane providing real-time 3D acquisition.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Davidh. Lymann
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)
દ-૨
{8}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 7 with i739 or t739 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | E | E | E |
| Small Organ[2] | E | E | E | | E | E | E | E | E | E |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | E | E | E |
| Musculo-skeletal Conventional | E | E | E | | E | E | E | E | E | E |
| Musculo-skeletal Superficial | E | E | E | | E | E | E | E | E | E |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative [5] (specify) | E | E | E | | E | E | E | E | E | E |
| Intraoperative Neurological | E | E | E | | E | E | E | E | E | E |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[5] Intraoperative includes abdominal, thoracic, and vascular.
["] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leggrom
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)
E-6
)
