(30 days)
No
The provided text describes a standard bone densitometer and does not mention any AI or ML capabilities.
No
The device is used for measurement, estimation, and analysis of bone mineral density and body composition, and the estimation of fracture risk. These are diagnostic functions, not therapeutic.
Yes
The device's intended use includes the measurement of bone mineral content (BMC), bone mineral density (BMD), estimation of fracture risk, and comparison to reference databases, all of which are diagnostic purposes related to assessing bone health.
No
The device is described as a "fan beam X-Ray Bone Densitometer," which is a hardware device that uses X-rays to measure bone density. The description does not indicate it is solely software.
Based on the provided information, the Hologic QDR Explorer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Hologic QDR Explorer is an X-ray bone densitometer. It uses X-rays to measure bone mineral content and density directly within the patient's body. This is an in vivo measurement, not an in vitro measurement of a specimen.
- Intended Use: The intended uses listed all involve direct measurement and analysis of the patient's body (bone density, body composition, fracture risk estimation) rather than analysis of a biological sample.
Therefore, the Hologic QDR Explorer falls under the category of diagnostic imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periprosthetic BMD.
Product codes
90 KGI
Device Description
The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periprosthetic BMD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Lumbar spine (L1, L2, L3, L4), Proximal femur (hip), Forearm (radius and ulna), Whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K992677, K983028, K963363, K961787, K002711
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Hologic, Inc. October 3, 2003 Hologic QDR Explorer X-Ray Bone Densitometer SPECIAL 510(k) Premarket Notification
Section E
510(k) Summary
000108
1
E. 510(k) Summary
E.1 Company Identification
Hologic, Inc. 35 Crosby Drive Bedford. MA 01730 781-999-7300
E.2 Contact Information
Daniel F. Phelan Senior Regulatory Affairs Specialist
E.3 Date of Submission
October 3, 2003
E.4 Device Identification
Proprietary Name Classification Name: Common/Usual Name Requlation Number: Product Code: Classification Classification Panel
Hologic QDR Explorer X-Ray Bone Densitometer Bone Densitometer Bone Densitometer 21 CFR 892.1170 90 KGI 11 Radiology
E.5 Predicate Device Information
- K943505 Hologic QDR-3000 X-Ray Bone Densitometer
- Hologic Discovery Package for QDR X-Ray Bone Densitometers K023398
E.6 Device Description and Intended Use
The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periproshtetic BMD.
000109
2
Hologic, Inc.
October 3, 2003
Hologic QDR Explorer X-Ray Bone Densitometer SPECIAL 510(k) Premarket Notification
KT333222
E.7 Substantial Equivalence
| QDR-3000 | QDR Explorer | |
|---|---|---|
| 510(k) Number | K943505 | |
| System Footprint | 3.02m (119 in) L x 1.50m (59 in) W x | |
| 1.42m (56 in) H +/- 25mm (1 in). | Same | |
| System Weight | 320 kg (720 lb) | 327 kg (729 lb) |
| System Power Requirements | 100V (23A), 120V (18A), and 230V | |
| (9A) models available | Same | |
| X-Ray Tube | Switched pulse dual-energy x-ray tube | |
| operating at 100 kV and 140 kV. 2.5 | ||
| mA average at 25% duty cycle. | ||
| Tungsten target | Same. | |
| Detector Array | 64 multichannel detector consisting of | |
| CdWO4 scintillators coupled to silicon | ||
| diodes | 54 multichannel detector consisting of | |
| CdWO4 scintillators coupled to silicon | ||
| diodes | ||
| X-Ray Source-to-Image-Detector | ||
| Distance | 1070 mm (42 in) +/- 8 mm (0.315 in) | 883.4 mm (34.8 in) +/- 8 mm (0.315 in) |
| X-Ray Source-to-Patient Distance | 424 mm (16.7 in) +/- 6 mm (0.236 in) | Same |
| Collimation | Aperture with 1.0 mm slit. | Same |
| Laser Positioning Device | Laser diode 1.0 GHz processor |
256 MB RAM
20 GB hard disk
3.5" 1.44 MB diskette drive
17" monitor (CRT)
120 MB SuperDisk drive
CD-ROM drive
16 MB video card
Standard keyboard and mouse | > 1.5 GHz processor
Same
Same
Same
17" monitor (CRT or LCD)
CD/RW drive
N/A
Same
Same |
| BMC Measurement | Standard | Same |
| BMD Measurement | Standard | Same |
| Fracture Risk Estimation (K983028) | Standard | Same |
| Reference Databases (K963363) | Standard | Same |
| Body Composition Analysis (K961787) | Optional | Same |
| Periprosthetic BMD Measurement
(K002711) | Optional | Same |
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2003
Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730-1401
Re: K033224 Trade/Device Name: Hologic ODR X-Ray Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: October 3, 2003 Received: October 6, 2003
Dear Mr. Phelan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
A.2 Indications for Use Statement
510(k) Number (if known): K033224
Device Name: Hologic QDR Explorer X-Ray Bone Densitometer
Indications for Use:
The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periprosthetic BMD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1)
Nancy C Brogdon
(Division Sign-Division of Reproductive and Radiological Devic 510(k) Number